NCT00519506

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 14, 2009

Status Verified

April 1, 2009

Enrollment Period

9 months

First QC Date

August 20, 2007

Last Update Submit

April 12, 2009

Conditions

Acute Pulmonary Embolism

Keywords

Pulmonary EmbolismPE

Outcome Measures

Primary Outcomes (1)

  • 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

    June 2008

Interventions

ThromboViewOTHER

Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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®.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

UCSD Medical Center

San Diego, California, 92103-3872, United States

Location

Henry Forde Hospital

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine at St. Louis

St Louis, Missouri, 63110, United States

Location

McMaster University Medical Center

Hamilton, Ontario, L8N3Z5, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, LBN4A6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21680946DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

thromboview

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Timothy Morris, MD

    UCSD Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

April 14, 2009

Record last verified: 2009-04

Locations

CA(2)US(4)