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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00808626
Recruitment Status : Withdrawn (Lack of funding to complete trial. A lead member of research team retired.)
First Posted : December 16, 2008
Last Update Posted : May 4, 2015
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Drug: 99mTc-rBitistatin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis
Study Start Date : December 2008
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi [ Time Frame: 1-4 hours after administration ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Alan H. Maurer, MD / Director of Nuclear Medicine, Temple University Hospital Identifier: NCT00808626     History of Changes
Other Study ID Numbers: 11556
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases