Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis
- Registration Number
- NCT00808626
- Lead Sponsor
- Temple University
- Brief Summary
99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms and legs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- peripheral acute venous thrombosis diagnosed by vascular ultrasound
- is able to give informed consent
- is likely to complete the study
Exclusion Criteria
- is pregnant
- is lactating
- has a history of prior severe allergic reactions (anaphylactic response)
- prior use of GP IIb/IIIa antagonist (e.g., abciximab, eptifibatide)
- has a platelet count <100,000 or history of thrombocytopenia
- has a history of stroke
- has a history of recent bleeding documented by decreasing hemoglobin (>1 gm) in last 7 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 99mTc-rBitistatin 99mTc-rBitistatin -
- Primary Outcome Measures
Name Time Method Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi 1-4 hours after administration
- Secondary Outcome Measures
Name Time Method Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously 0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration
Trial Locations
- Locations (1)
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States