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

Sponsored by:	Temple University
Information provided by:	Temple University
ClinicalTrials.gov Identifier:	NCT00808626

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 I Phase II

MedlinePlus related topics: Deep Vein Thrombosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

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 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
99mTc-rBitistatin: Experimental	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.

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
will not be receiving heparin as treatment
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

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

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thrombosis
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009