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

Primary Purpose

Venous Thrombosis

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

99mTc-rBitistatin

About this trial

This is an interventional diagnostic trial for Venous Thrombosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Temple University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

99mTc-rBitistatin

Arm Description

Outcomes

Primary Outcome Measures

Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi

Secondary Outcome Measures

Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously

Full Information

NCT ID

NCT00808626

First Posted

December 12, 2008

Last Updated

May 1, 2015

Sponsor

Temple University

1. Study Identification

Unique Protocol Identification Number

NCT00808626

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding to complete trial. A lead member of research team retired.

Study Start Date

December 2008 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Temple University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thrombosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

99mTc-rBitistatin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

99mTc-rBitistatin

Other Intervention Name(s)

Bitistatin, HN-Bitistatin, 99mTc-Bitis, Bitis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi

Time Frame

1-4 hours after administration

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan H Maurer, MD

Organizational Affiliation

Temple University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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