Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

Venous Thrombosis Clinical Trial

Official title:

Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00808626
• Other study ID #: 11556
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: December 12, 2008
• Last updated: May 1, 2015
• Start date: December 2008
• Est. completion date: March 2017

Study information

• Verified date: May 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• 99mTc-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.

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi		1-4 hours after administration	No
Secondary	Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously		0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration	Yes