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A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02142608
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : August 27, 2020
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Drug: BR55
Enrollment 19
Recruitment Details 19 patients were recruited, but only 18 were dosed. Of the 18 dosed, 4 were training cases evaluated for safety only. Of the remaining 14 patients, 1 had no evaluable images; therefore, only 13 patients were included in the Efficacy Population.
Pre-assignment Details

One participant was not dosed with BR55.

Patient signed informed consent but did not receive investigational product. During pre-dose safety evaluations, it was discovered that patient may have potentially clinical significant abnormal ECGs (atrial fibrillation).

Arm/Group Title BR55
Hide Arm/Group Description All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title BR55
Hide Arm/Group Description All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
62.6  (4.68)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
18-64 years
12
  66.7%
>= 65 years
6
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.6%
Black
1
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
White
16
  88.9%
Other
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 18 participants
83.62  (15.573)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 18 participants
172.6  (8.71)
1.Primary Outcome
Title Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
Hide Description To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
Time Frame Within 30 minutes after administration of BR55
Hide Outcome Measure Data
Hide Analysis Population Description
BR55 binding level versus Gleason score in malignant lesions from off-site histopathology
Arm/Group Title BR55
Hide Arm/Group Description:
Ultrasound Image Assessment
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: number of lesions
Gleason score ≥7 17
With binding 8
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description To obtain safety data in subjects administered BR55
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BR55
Hide Arm/Group Description:
All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Number of subjects with AEs 1
Number of subjects with AEs by intensity - Mild 1
Number of subjects with AEs by intensity -Moderate 0
Number of subjects with AEs by intensity - Severe 0
Number of subjects with serious AEs 0
Number of subjects who discontinued due to AEs 0
Number of deaths 0
Time Frame All adverse events that occurred from the time the patient signed the Informed Consent Form until 24 hours after the last administration of BR55 were recorded.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BR55
Hide Arm/Group Description All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg
All-Cause Mortality
BR55
Affected / at Risk (%)
Total   0/18 (0.00%)    
Hide Serious Adverse Events
BR55
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BR55
Affected / at Risk (%) # Events
Total   1/18 (5.56%)    
Gastrointestinal disorders   
Diarrhea  1  1/18 (5.56%)  1
Nervous system disorders   
Headache  1  1/18 (5.56%)  1
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
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: Maria Luigia Storto, MD, Executive Director X-Ray and Ultrasound
Organization: Bracco Diagnostics Inc.
Phone: 609-514-2262
EMail: marialuigia.storto@diag.bracco.com
Layout table for additonal information
Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT02142608    
Other Study ID Numbers: BR55-105
First Submitted: May 16, 2014
First Posted: May 20, 2014
Results First Submitted: August 11, 2020
Results First Posted: August 27, 2020
Last Update Posted: March 29, 2021