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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00808626
First received: December 12, 2008
Last updated: August 3, 2011
Last verified: December 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 10
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808626

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

No publications provided

Responsible Party: Alan H. Maurer, MD / Director of Nuclear Medicine, Temple University Hospital
ClinicalTrials.gov Identifier: NCT00808626     History of Changes
Other Study ID Numbers: 11556
Study First Received: December 12, 2008
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013