99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
Stopped: Sponsor Decision based on strategic considerations
Canada39 participantsStarted 2016-06-23
Plain-language summary
This was a single-center, single-dose, study comprising a Proof of Concept (PoC) part and a subsequent Phase II part. The study was being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to image atherosclerotic plaque that might rupture and break off artery walls. This is caused by apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up on any artery in the body.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females age 18 years or greater
✓. Able and willing to comply with the study procedures
✓. Negative pregnancy test for women of childbearing potential at screening and on the day of administration of 99mTc-rhAnnexin V-128.
✓. Evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years;
✓. Evidence of 50% or more carotid stenosis in the most recent US imaging within 8 weeks prior to 99mTc-rhAnnexin V-128 administration
✓. No significant carotid artery disease on carotid ultrasound;
✓. No clinically significant abnormalities in baseline laboratory values.
Exclusion criteria
✕. Previous carotid stending, endarterectomy or stroke;
✕. Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans);
What they're measuring
1
Number of Participants Evaluated for Imaging Feasibility
Timeframe: Day 0
2
Percentage of Participants With Prevalence of Abnormal 99mTc-rhAnnexin V-128 SPECT/CT Imaging (Phase II Step)
Timeframe: At 60 and 120 minutes post injection on Day 0
✕. History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment;
✕. Know hypersensitivity to the investigational product or any of its components;
✕. Claustrophobia or inability to lie still in a supine position;
✕. Participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration;