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Infrared Lymphangiography as a Method of Sentinel Node Identification (SPY-SN)

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ClinicalTrials.gov Identifier: NCT02057393
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Colette Pameijer, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Melanoma
Sentinel Node
Interventions Drug: Indocyanine green
Drug: Technetium99
Drug: Methylene blue
Enrollment 89
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indocyanine Green
Hide Arm/Group Description

Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.

Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.

Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.

Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.

Period Title: Overall Study
Started 89
Completed 87
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Patient did not meet criteria             1
Arm/Group Title Indocyanine Green
Hide Arm/Group Description

Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.

Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.

Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.

Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.

Overall Number of Baseline Participants 87
Hide Baseline Analysis Population Description
89 subjects were enrolled, one subject retracted consent, and another was deemed ineligible after enrollment, leaving 87 evaluable participants.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 87 participants
65
(26 to 94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
Female
45
  51.7%
Male
42
  48.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 87 participants
87
 100.0%
BMI  
Median (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 87 participants
28
(17 to 51.5)
1.Primary Outcome
Title Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes
Hide Description The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indocyanine Green
Hide Arm/Group Description:

Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.

Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.

Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.

Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.

Overall Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: number of sentinel nodes per patient
1.87  (0.95)
Time Frame 2 weeks post-op
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indocyanine Green
Hide Arm/Group Description

Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.

Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.

Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.

Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.

All-Cause Mortality
Indocyanine Green
Affected / at Risk (%)
Total   0/87 (0.00%) 
Hide Serious Adverse Events
Indocyanine Green
Affected / at Risk (%)
Total   0/87 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Indocyanine Green
Affected / at Risk (%)
Total   0/87 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Colette Pameijer, Associate Professor of Surgery
Organization: Penn State Hershey Medical Center
Phone: 717-531-5272
EMail: cpameijer@pennstatehealth.psu.edu
Layout table for additonal information
Responsible Party: Colette Pameijer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02057393    
Other Study ID Numbers: 247374
First Submitted: January 24, 2014
First Posted: February 7, 2014
Results First Submitted: March 17, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 6, 2017