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

This study has been withdrawn prior to enrollment.
(Lack of funding to complete trial. A lead member of research team retired.)
Information provided by:
Temple University Identifier:
First received: December 12, 2008
Last updated: May 1, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Venous Thrombosis
Drug: 99mTc-rBitistatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

Resource links provided by NLM:

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi [ Time Frame: 1-4 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously [ Time Frame: 0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2008
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 99mTc-rBitistatin 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.
Other Names:
  • Bitistatin
  • HN-Bitistatin
  • 99mTc-Bitis
  • Bitis


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00808626

United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Study Director: Alan H Maurer, MD Temple University Hospital
  More Information

Responsible Party: Alan H. Maurer, MD / Director of Nuclear Medicine, Temple University Hospital Identifier: NCT00808626     History of Changes
Other Study ID Numbers: 11556 
Study First Received: December 12, 2008
Last Updated: May 1, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases processed this record on May 22, 2016