BR55 in Prostate Cancer: an Exploratory Clinical Trial

NCT01253213 | Completed Early Phase 1

• 1 other identifier: BR55-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer

Keywords

Prostate cancer; Ultrasound molecular imaging; Contrast agent; BR55; VEGFR2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• BR55 specificity assessment

  Day 1

Study Arms (1)

BR55

EXPERIMENTAL

Drug: BR55

Interventions

BR55 DRUG

One to two bolus (2nd bolus optional) of BR55 per patient

BR55

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead
• Bracco Imaging S.p.A.: collaborator

Study Sites (1)

AMC University Amsterdam

Amsterdam, 1100 DD, Netherlands

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

Study Officials

• Hessel Wijkstra, Dr.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 1, 2023

Record last verified: 2013-04

Locations

NL (1)