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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This study has been withdrawn prior to enrollment.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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases processed this record on August 18, 2017