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Safety of PDT-Photofrin® Prior to Lung Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03344861
Recruitment Status : Completed
First Posted : November 17, 2017
Results First Posted : January 2, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Concordia Laboratories Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Lung Cancer
Lung Cancer Metastatic
Interventions Drug: Porfimer Sodium
Device: Fiber optic
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Photofrin and Photodynamic Therapy
Hide Arm/Group Description Open label study. All subjects had a 1-time administration of Photofrin and 1-time use of navigational bronchoscopy-PDT.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  70.0%
>=65 years
3
  30.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Peripheral Lung Tumor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Safety: Number of Participants With at Least One Adverse Event
Hide Description Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Time Frame 108 days (to 3 months post surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Photodynamic Therapy-Photofrin
Comments Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.
Type of Statistical Test Other
Comments No comparator arm.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method exact Clopper-Pearson binomial method
Comments One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.
Method of Estimation Estimation Parameter Clopper-Pearson (binomial proportion)
Estimated Value .05
Estimation Comments One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion
2.Primary Outcome
Title Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Hide Description Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Time Frame 108 days (to 3 months post surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Respiratory abnormal at screening
1
  10.0%
Respiratory abnormal at Follow-up (Day 103-108)
3
  30.0%
Mouth abnormal at Follow-up (day 103-108)
1
  10.0%
3.Primary Outcome
Title Safety: Vital Sign Summary of Abnormal Findings for Each Subject
Hide Description Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Time Frame 108 days (to 3 months post surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Primary Outcome
Title Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Hide Description Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Time Frame 108 days (to 3 months post surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Albumin (105-04) Period 1: 32 (drop of 10)
1
  10.0%
Lab values with no clinically significant change
9
  90.0%
5.Primary Outcome
Title Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
Hide Description Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
Time Frame 108 days (to 3 months post surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
4
  40.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Photodynamic Therapy-Photofrin
Comments All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as "reasonable possibility" on the CRF (Case Report Form).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method exact Clopper-Pearson binomial method
Comments One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.
6.Secondary Outcome
Title Macroscopic Tissue Examination
Hide Description The mean measurement of tumor size after surgery. The largest diameter seen is measured.
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
Photodynamic therapy - Photofrin
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: CM
2.177  (0.8003)
7.Secondary Outcome
Title Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
Hide Description The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
Look at complete response in the tumor area
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
20
8.Secondary Outcome
Title Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
Hide Description The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were examined for percent tumor cell necrosis in the tumor area
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Percent of tumor
22.0  (17.67)
9.Secondary Outcome
Title Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
Hide Description The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
The brisk inflammatory reaction percentage seen in the tumor area
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
10.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
Hide Description The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with cavitation seen in normal lung area
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
  10.0%
11.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
Hide Description The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with Hemorrhage seen in normal lung area after surgery
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
6
  60.0%
12.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
Hide Description The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
Microscopic Tissue Examination: Pneumonitis in the normal lung after surgery. Looked at Number of Participants with pneumonitis.
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
13.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
Hide Description The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
14.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
Hide Description Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with Atypical/Reactive Type 2 Pneumocytes in the normal lung after surgery determined during the Microscopic Tissue Examination.
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
15.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
Hide Description Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
16.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Hide Description Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
0
   0.0%
Moderate
1
  10.0%
Severe
0
   0.0%
None
9
  90.0%
17.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
Hide Description Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with Necrosis in the normal lung after surgery
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
3
  30.0%
18.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
Hide Description Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
  10.0%
19.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
Hide Description Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
20.Secondary Outcome
Title Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
Hide Description Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
21.Secondary Outcome
Title ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
Hide Description Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame Baseline (-30 to -1 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
ECOG 0
7
  70.0%
ECOG 1
3
  30.0%
22.Secondary Outcome
Title ECOG Performance Status: Period 1 PDT Day 3
Hide Description Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
ECOG 0
6
  60.0%
ECOG 1
4
  40.0%
23.Secondary Outcome
Title ECOG Performance Status: Period II Surgery (Day 13-18)
Hide Description Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame Day 13 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
ECOG 0
7
  70.0%
ECOG 1
3
  30.0%
24.Secondary Outcome
Title ECOG Performance Status: Period III Follow-up (Day 20-25)
Hide Description Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame Day 20 to 25
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
ECOG 0
0
   0.0%
ECOG 1
9
  90.0%
ECOG 2
1
  10.0%
25.Secondary Outcome
Title ECOG Performance Status: Period III Follow-up (Day 43 -48)
Hide Description Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame Day 43 to 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
ECOG 0
7
  70.0%
ECOG 1
3
  30.0%
26.Secondary Outcome
Title ECOG Performance Status: Period III Follow-up (Day 103 - 108)
Hide Description Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame 108 days (to 3 months post surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description:

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
ECOG 0
9
  90.0%
ECOG 1
1
  10.0%
Time Frame Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Photodynamic Therapy-Photofrin
Hide Arm/Group Description

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

All-Cause Mortality
Photodynamic Therapy-Photofrin
Affected / at Risk (%)
Total   0/10 (0.00%)    
Hide Serious Adverse Events
Photodynamic Therapy-Photofrin
Affected / at Risk (%) # Events
Total   4/10 (40.00%)    
Blood and lymphatic system disorders   
Hemorrhagic Shock  1 [1]  1/10 (10.00%)  1
Anemia  1 [2]  1/10 (10.00%)  1
Deep Vein Thrombosis (DVT) Right  1 [3]  1/10 (10.00%)  1
Deep Vein Thrombosis Left  1 [4]  1/10 (10.00%)  1
Cardiac disorders   
Atrial Fibrillation  1 [5]  1/10 (10.00%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1 [6]  1/10 (10.00%)  1
Gastro-oesophageal reflux disease  1 [7]  1/10 (10.00%)  1
Infections and infestations   
Sepsis  1 [8]  1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1 [9]  1/10 (10.00%)  1
Hypoxia  1 [10]  1/10 (10.00%)  1
Haemothorax  1 [11]  1/10 (10.00%)  1
Dyspnoea  1 [12]  1/10 (10.00%)  1
Pneumonia aspiration  1 [13]  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
[1]
Subject hospitalized for scheduled right colectomy for colon cancer and experienced hemorrhagic shock (CTCAE Grade 4).
[2]
Subject hospitalized for scheduled right colectomy for colon cancer and experienced anemia CTCAE Grade 3.
[3]
Hospitalized with CTCAE Grade 3 deep vein thrombosis right.
[4]
While hospitalized with DVT Right, subject experienced a CTCAE Grade 2 SAE of deep vein thrombosis left.
[5]
Subject hospitalized for scheduled right colectomy for colon cancer and experienced atrial fibrillation with rapid ventricular response CTCAE Grade 2 that converted to sinus.
[6]
On Study Day 4, subject received 2 doses of Toradol and on that same day complained of stomachache. On Study Days 4 & 5 subject had diarrhea. On Study Day 5 subject was diagnosed with moderate gastrointestinal bleed (CTCAE Grade 2).
[7]
While hospitalized for sepsis and pneumonia aspiration, subject experience CTCAE Grade 2 SAE (Serious Adverse Event) of gastrooesophageal reflux disease
[8]
Subject hospitalized with symptoms of cough, fever and chills resulting from sepsis CTCAE Grade 1.
[9]
Subject hospitalized for scheduled right colectomy for colon cancer and experienced pleural effusion (recurrent right pleural effusion CTCAE Grade 2).
[10]
Subject hospitalized for scheduled right colectomy for colon cancer and experienced acute hypoxemic respiratory failure CTCAE Grade 4.
[11]
Subject hospitalized for scheduled right colectomy for colon cancer and experienced iatrogenic right haemothorax CTCAE Grade 3 diagnosed from CT angiogram.
[12]
Subject hospitalized for scheduled right colectomy for colon cancer and experienced dyspnoea CTCAE Grade 2.
[13]
Hospitalized with pneumonia aspiration CTCAE Grade 2 along with sepsis.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Photodynamic Therapy-Photofrin
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Cardiac disorders   
Bradycardia  1  2/10 (20.00%)  3
Tachycardia  1  1/10 (10.00%)  1
Congenital, familial and genetic disorders   
Congenital diaphragmatic hernia  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Constipation  1  2/10 (20.00%)  2
Gastritis  1  1/10 (10.00%)  1
Nausea  1  2/10 (20.00%)  2
Vomiting  1  1/10 (10.00%)  1
General disorders   
Tenderness  1  1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Procedural Pain  1  2/10 (20.00%)  3
Investigations   
Blood albumin decreased  1  4/10 (40.00%)  4
Blood alkaline phosphatase decreased  1  1/10 (10.00%)  2
Blood creatinine decreased  1  2/10 (20.00%)  4
Blood creatinine increased  1  5/10 (50.00%)  7
Blood glucose increased  1  3/10 (30.00%)  6
Blood pressure increased  1  3/10 (30.00%)  8
Blood pressure decreased  1  1/10 (10.00%)  2
Blood urea abnormal  1  2/10 (20.00%)  3
Blood urea increased  1  1/10 (10.00%)  1
Chest x-ray abnormal  1  1/10 (10.00%)  2
False negative investigation result  1  3/10 (30.00%)  6
Hematocrit decreased  1  2/10 (20.00%)  2
Hematocrit increased  1  2/10 (20.00%)  2
Hemoglobin decreased  1  3/10 (30.00%)  4
Hemoglobin increased  1  2/10 (20.00%)  2
Heart rate increased  1  1/10 (10.00%)  1
Platelet count increased  1  1/10 (10.00%)  1
Protein total decreased  1  1/10 (10.00%)  1
Prothrombin time abnormal  1  2/10 (20.00%)  2
Prothrombin time prolonged  1  2/10 (20.00%)  2
Red blood cell count decreased  1  2/10 (20.00%)  2
Red blood cell count increased  1  1/10 (10.00%)  1
Respiratory rate increased  1  1/10 (10.00%)  1
White blood cell count increased  1  2/10 (20.00%)  4
x-ray abnormal  1  1/10 (10.00%)  1
Blood Sodium increased  1  1/10 (10.00%)  1
Prothrombin time shortened  1  1/10 (10.00%)  1
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/10 (10.00%)  2
Hyperkalaemia  1  1/10 (10.00%)  2
Hypokalaemia  1  2/10 (20.00%)  2
Hyponatraemia  1  1/10 (10.00%)  2
Protein deficiency  1  1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma  1  1/10 (10.00%)  1
Lung neoplasm malignant  1  1/10 (10.00%)  2
Neoplasm  1  2/10 (20.00%)  2
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  4/10 (40.00%)  4
Dyspnoea  1  1/10 (10.00%)  4
Hypoxia  1  1/10 (10.00%)  2
Pneumothorax  1  5/10 (50.00%)  7
Respiratory abnormal  1  1/10 (10.00%)  1
Pleural effusion  1  6/10 (60.00%)  7
Skin and subcutaneous tissue disorders   
Swelling Face  1 [1]  1/10 (10.00%)  1
Facial Blisters  1 [2]  1/10 (10.00%)  1
Forearm Erythema  1 [3]  2/10 (20.00%)  2
Hand Erythema  1 [4]  1/10 (10.00%)  1
Facial erythema  1 [5]  2/10 (20.00%)  3
Erythema on calves  1 [6]  1/10 (10.00%)  1
Abdomen erythema  1 [7]  1/10 (10.00%)  1
Hyperhidrosis  1  1/10 (10.00%)  1
Surgical and medical procedures   
Thoracic operation  1  1/10 (10.00%)  1
Vascular disorders   
Hypertension  1  2/10 (20.00%)  6
Hypotension  1  1/10 (10.00%)  2
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
[1]
Face swelling due to photosensitivity reaction.
[2]
Blisters on face due to photosensitivity to drug.
[3]
Skin erythema on both forearms
[4]
Mild hand erythema from photosensitivity to study drug.
[5]
Dermal erythema (sunburn) on face due to photosensitivity to study drug
[6]
Dermal erythema (sunburn) on calves due to photosensitivity to study drug
[7]
Abdomen redness due to photosensitivity to study drug.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kim McDonald-Taylor
Organization: on behalf of Concordia Laboratories Inc.
Phone: 647-267-2942
EMail: kmcdonald-taylor@rogers.com
Layout table for additonal information
Responsible Party: Concordia Laboratories Inc.
ClinicalTrials.gov Identifier: NCT03344861    
Other Study ID Numbers: CLI-PHO1701
First Submitted: November 13, 2017
First Posted: November 17, 2017
Results First Submitted: October 26, 2019
Results First Posted: January 2, 2020
Last Update Posted: January 13, 2020