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A Phase II Study to Evaluate the Efficacy of ThromboView® in the Detection of Pulmonary Emboli

Primary Purpose

Acute Pulmonary Embolism

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ThromboView

About this trial

This is an interventional diagnostic trial for Acute Pulmonary Embolism focused on measuring Pulmonary Embolism, PE

Eligibility Criteria

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

Inclusion Criteria:

Written consent by the subject to participate in the study.
Moderate to high pre-test probability of acute pulmonary embolism.
Positive D-dimer.
Onset of PE symptoms occurring within the last seven days.
Aged 18 years or older.
Women of childbearing potential must have a negative serum pregnancy test (β-hCG) result at the time of enrollment into the study. Both male and female participants must agree to use effective contraception for the first 30 days after administration of 99mTc ThromboView®.

Exclusion Criteria:

The subject is unwilling or unable to provide written informed consent.
Allergy or other contraindication to intravenous iodinated contrast media.
Prior exposure to murine, chimeric or humanized antibodies.
Illicit intravenous drug use in the past 12 months.
Administration of therapeutic radioiodine in the past 6 months.
Life expectancy less than 90 days.
Previous participation in the current study.
Current enrollment in a clinical trial involving any other investigational agent.
Subject is unsuitable for SPECT scanning at the study Investigator's discretion (e.g. residual detectable radioactivity within the lungs due to prior imaging studies or treatment, preceding planned administration of 99mTc ThromboView®).
Inability to perform CTPA or 99mTc ThromboView imaging, for any reason.
Renal dysfunction: calculated creatinine clearance < 30 mL/min.
Hepatic dysfunction: serum transaminases ≥ 3 x upper limit of normal range.
Hepatic dysfunction: subject has history of chronic or currently active liver disease.
Current pregnancy or lactation or conception intended within three months of enrollment.
Subject is unsuitable for the study at the study Investigator's discretion. -

Sites / Locations

UC Davis Medical Center
UCSD Medical Center
Henry Forde Hospital
Washington University School of Medicine at St. Louis
McMaster University Medical Center
St. Joseph's Hospital

Outcomes

Primary Outcome Measures

Provide estimates of the sensitivity of 99mTc ThromboView® in subjects with confirmed PE, as determined by computed tomographic pulmonary angiography (CTPA) and the specificity of 99mTc ThromboView® in subjects with PE excluded by CTPA

Secondary Outcome Measures

Full Information

NCT ID

NCT00519506

First Posted

August 20, 2007

Last Updated

April 12, 2009

Sponsor

Agen Biomedical

1. Study Identification

Unique Protocol Identification Number

NCT00519506

Brief Title

A Phase II Study to Evaluate the Efficacy of ThromboView® in the Detection of Pulmonary Emboli

Official Title

A Phase II Study to Evaluate the Efficacy of Anti-Fibrin Humanized Monoclonal Antibody(DI-DD3B6/22-80B3) Fab' Fragment (ThromboView®) Conjugated With Technetium-99m in the Detection of Pulmonary Emboli

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Agen Biomedical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a moderate to high clinical suspicion for PE.

6. Conditions and Keywords

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

Acute Pulmonary Embolism

Keywords

Pulmonary Embolism, PE

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

ThromboView

Intervention Description

Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism

Primary Outcome Measure Information:

Title

Time Frame

June 2008

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written consent by the subject to participate in the study. Moderate to high pre-test probability of acute pulmonary embolism. Positive D-dimer. Onset of PE symptoms occurring within the last seven days. Aged 18 years or older. Women of childbearing potential must have a negative serum pregnancy test (β-hCG) result at the time of enrollment into the study. Both male and female participants must agree to use effective contraception for the first 30 days after administration of 99mTc ThromboView®. Exclusion Criteria: The subject is unwilling or unable to provide written informed consent. Allergy or other contraindication to intravenous iodinated contrast media. Prior exposure to murine, chimeric or humanized antibodies. Illicit intravenous drug use in the past 12 months. Administration of therapeutic radioiodine in the past 6 months. Life expectancy less than 90 days. Previous participation in the current study. Current enrollment in a clinical trial involving any other investigational agent. Subject is unsuitable for SPECT scanning at the study Investigator's discretion (e.g. residual detectable radioactivity within the lungs due to prior imaging studies or treatment, preceding planned administration of 99mTc ThromboView®). Inability to perform CTPA or 99mTc ThromboView imaging, for any reason. Renal dysfunction: calculated creatinine clearance < 30 mL/min. Hepatic dysfunction: serum transaminases ≥ 3 x upper limit of normal range. Hepatic dysfunction: subject has history of chronic or currently active liver disease. Current pregnancy or lactation or conception intended within three months of enrollment. Subject is unsuitable for the study at the study Investigator's discretion. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy Morris, MD

Organizational Affiliation

UCSD Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

UCSD Medical Center

City

San Diego

State/Province

California

ZIP/Postal Code

92103-3872

Country

United States

Facility Name

Henry Forde Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Washington University School of Medicine at St. Louis

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

McMaster University Medical Center

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N3Z5

Country

Canada

Facility Name

St. Joseph's Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

LBN4A6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21680946

Citation

Morris TA, Gerometta M, Yusen RD, White RH, Douketis JD, Kaatz S, Smart RC, Macfarlane D, Ginsberg JS. Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab' fragments (ThromboView). Am J Respir Crit Care Med. 2011 Sep 15;184(6):708-14. doi: 10.1164/rccm.201104-0624OC. Epub 2011 Jun 16.

Results Reference

derived

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A Phase II Study to Evaluate the Efficacy of ThromboView® in the Detection of Pulmonary Emboli

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