A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
![]() |
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: NCT02142608 |
Recruitment Status :
Completed
First Posted : May 20, 2014
Results First Posted : August 27, 2020
Last Update Posted : November 4, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: BR55 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2 |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: BR55
All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
|
Drug: BR55
Ultrasound contrast agent |
- Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging [ Time Frame: Within 30 minutes after administration of BR55 ]To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
- Number of Participants With Adverse Events [ Time Frame: 24 hours post-dose ]To obtain safety data in subjects administered BR55

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male, age between 50-70 years old
- Increased PSA level >4 ng/mL
- Known prostate cancer
- Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)
- Provided written informed consent and willing to comply with protocol requirements
Exclusion Criteria:
- Documented acute prostatitis or urinary tract infections
- Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease
- History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts
- Severe cardiac rhythm disorders within the last 7 days
- Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
- Received a prostate biopsy procedure within 30 days before admission into the study
- Determined by investigator to be clinically unsuitable for the study
- Participated in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142608
United States, California | |
Translational Molecular Imaging Lab | |
Stanford, California, United States, 94305 | |
France | |
Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte | |
Bordeaux, France |
Study Director: | Maria Luigia Storto, M.D. | Bracco Diagnostics, Inc |
Responsible Party: | Bracco Diagnostics, Inc |
ClinicalTrials.gov Identifier: | NCT02142608 |
Other Study ID Numbers: |
BR55-105 |
First Posted: | May 20, 2014 Key Record Dates |
Results First Posted: | August 27, 2020 |
Last Update Posted: | November 4, 2020 |
Last Verified: | March 2015 |
Prostate cancer Ultrasound Imaging |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |