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

NCT02142608 | Completed Phase 1 Results

• 1 other identifier: BR55-105
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 2

Brief Summary

Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results

Conditions

Prostate Cancer

Keywords

Prostate cancer; Ultrasound Imaging

Outcome Measures

Primary Outcomes (1)

• Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging

  To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard

  Within 30 minutes after administration of BR55

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  24 hours post-dose

Study Arms (1)

BR55

EXPERIMENTAL

All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...

Drug: BR55

Interventions

BR55 DRUG

Ultrasound contrast agent

BR55

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age between 50-70 years old
• Increased Prostate-Specific Antigen (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (2)

Translational Molecular Imaging Lab

Stanford, California, 94305, United States

Location

Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte

Bordeaux, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Maria Luigia Storto, MD, Executive Director X-Ray and Ultrasound
• Organization: Bracco Diagnostics Inc.

marialuigia.storto@diag.bracco.com

609-514-2262

Study Officials

• Maria Luigia Storto, M.D.

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 29, 2021
• Results First Posted: August 27, 2020

Record last verified: 2021-03

Locations

FR (1); US (1)