BR55 in Prostate Cancer: an Exploratory Clinical Trial

Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2

The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging.

This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: BR55

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1100 DD
    • AMC University Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male patient, age ≥ 40 years old
• Has a histology proven focal prostate cancer lesion
• The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
• Provides written Informed Consent and is willing to comply with protocol requirement

Exclusion Criteria:

• Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study
• Has documented acute prostatitis or urinary tract infections
• Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease
• With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
• Has had severe cardiac rhythm disorders within the last 7 days
• Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
• Has received a prostate biopsy procedure within 30 days before admission into this study
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
• Is determined by the Investigator that the patient is clinically unsuitable for the study.
• Is incapable of understanding the language in which the information for the patient is given
• Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BR55	Drug: BR55; One to two bolus (2nd bolus optional) of BR55 per patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BR55 sensitivity assessment	Assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BR55 specificity assessment	Evaluate the specificity of BR55 targeting for prostate cancer relative to normal prostate gland on the basis of a visual score in comparison with routine histopathology analysis and IHC assessment of VEGFR2 expression in tissue specimens.	Day 1

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Collaborators: Bracco Imaging S.p.A.
• Investigators: Principal Investigator: Hessel Wijkstra, Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimated): December 3, 2010

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Prostate cancer; VEGFR2; Contrast agent; Ultrasound molecular imaging; BR55
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BR55-101