Status:
COMPLETED
Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis
Lead Sponsor:
Agen Biomedical
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical scenario that, despite major advances in diagnostic testing, continues to be challenging. The diagnosis of DV...
Eligibility Criteria
Inclusion
- Adult man or woman, aged ≥18 years, presenting with suspected lower-limb initial or recurrent DVT.
- Moderate or high pre-test probability (PTP) for DVT.
- Onset of symptoms occurred within the last 7 days.
- Women of childbearing potential to have a negative pregnancy test as determined by measuring serum β-hCG levels at time of study enrolment.
Exclusion
- Receiving anticoagulant therapy at therapeutic doses for \>3 days.
- Life expectancy \<3 months.
- Patient with a renal transplant.
- Renal dysfunction: serum creatinine \>1.5x upper limit of normal range.
- Hepatic dysfunction: serum transaminases \>3x upper limit of normal range.
- Current pregnancy or lactation; or conception intended within 90 days of enrolment
- Of childbearing potential and unwilling to use adequate contraception for 30 days following enrolment
- Unable to undergo lower limb ascending venography on symptomatic leg(s).
- Allergy or other contraindication to intravenous contrast dye.
- Prior exposure to murine or humanized antibodies.
- Prior imaging studies with: I131 within the last month; In111 or Ga67 within the last 2 weeks; Tc99m labelled RBCs, WBCs or albumin within the last 48 hours; Tc99m or F18 within the last 24 hours; prior non-imaging, non-therapeutic nuclear medicine studies with I131 (eg., 24-hour RAI uptake) within the last 2 weeks.
- Previous participation in the present study.
- Geographic inaccessibility that precludes follow-up visits.
- Patient is unwilling or unable to provide informed consent.
- Patient is unsuitable for the study, at the Study Investigator's discretion.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00123734
Start Date
March 1 2005
End Date
May 1 2006
Last Update
August 24 2009
Active Locations (12)
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1
UC Davis
Sacramento, California, United States, 95817
2
UCSD Medical Centre
San Diego, California, United States, 82103-9378
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195