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

Acute Pulmonary Embolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519506
• Other study ID #: CAN/US-002-II-PE
• 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
• 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. -

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

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