Phase II Investigation of 99mTc-rBitistatin for Imaging V... | NCT00808626

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

NCT00808626

Sponsor

Temple University

Status

Withdrawn

Last Update Posted

May 4, 2015Estimated

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Venous Thrombosis

Interventions

99mTc-rBitistatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Dec 12, 2008

First Submission Date that Met QC Criteria

Dec 12, 2008

First Posted Date

Dec 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2015

Last Update Posted Date

May 4, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
99mTc-rBitistatin	Experimental		Drug: 99mTc-rBitistatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
99mTc-rBitistatin	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi		1-4 hours after administration

Secondary Outcomes

Measure	Description	Time Frame
Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously		0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan H Maurer, MD	Temple University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temple University Hospital		Philadelphia	Pennsylvania	19140	United States

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C062186	bitistatin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided