BR55 in Prostate Cancer: an Exploratory Clinical Trial

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253213
• Other study ID #: BR55-101
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	AMC University Amsterdam	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc	Bracco Imaging S.p.A.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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