Venous Thrombosis
Conditions
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.
Interventions
DRUG99mTc-rBitistatin
Intravenous administration of a single dose (10 mCi, 0.1 ug/kg body weight) of 99mTc-rBitistatin, followed by collection of scintigraphic (planar and SPECT) images at 1 hour and 2-4 hours.
Sponsors
Temple University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi | 1-4 hours after administration |
Secondary
| Measure | Time frame |
|---|---|
| Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously | 0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration |
Countries
United States
Outcome results
None listed