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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00519506
Other study ID # CAN/US-002-II-PE
Secondary ID
Status Completed
Phase Phase 2
First received August 20, 2007
Last updated April 12, 2009
Start date September 2007
Est. completion date October 2008

Study information

Verified date April 2009
Source Agen Biomedical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Written consent by the subject to participate in the study.

2. Moderate to high pre-test probability of acute pulmonary embolism.

3. Positive D-dimer.

4. Onset of PE symptoms occurring within the last seven days.

5. Aged 18 years or older.

6. Women of childbearing potential must have a negative serum pregnancy test (ß-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:

1. The subject is unwilling or unable to provide written informed consent.

2. Allergy or other contraindication to intravenous iodinated contrast media.

3. Prior exposure to murine, chimeric or humanized antibodies.

4. Illicit intravenous drug use in the past 12 months.

5. Administration of therapeutic radioiodine in the past 6 months.

6. Life expectancy less than 90 days.

7. Previous participation in the current study.

8. Current enrollment in a clinical trial involving any other investigational agent.

9. 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®).

10. Inability to perform CTPA or 99mTc ThromboView imaging, for any reason.

11. Renal dysfunction: calculated creatinine clearance < 30 mL/min.

12. Hepatic dysfunction: serum transaminases = 3 x upper limit of normal range.

13. Hepatic dysfunction: subject has history of chronic or currently active liver disease.

14. Current pregnancy or lactation or conception intended within three months of enrollment.

15. Subject is unsuitable for the study at the study Investigator's discretion. -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ThromboView
Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism

Locations

Country Name City State
Canada McMaster University Medical Center Hamilton Ontario
Canada St. Joseph's Hospital Hamilton Ontario
United States Henry Forde Hospital Detroit Michigan
United States UC Davis Medical Center Sacramento California
United States UCSD Medical Center San Diego California
United States Washington University School of Medicine at St. Louis St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Agen Biomedical

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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