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

Phase 0
40 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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

- Has any medical condition or other circumstances which would significantly decrease
the chances of obtaining reliable data, achieving study objectives, or completing the

- Is determined by the Investigator that the patient is clinically unsuitable for the

- 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;

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

BR55 sensitivity assessment

Outcome Description:

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).

Outcome Time Frame:

Day 1

Safety Issue:


Principal Investigator

Hessel Wijkstra, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

July 2010

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Ultrasound molecular imaging
  • Contrast agent
  • BR55
  • VEGFR2
  • Prostatic Neoplasms