99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
Condition: Carotid Artery Plaque
MeSH terms: Carotid Stenosis
Intervention: 99mTc-rhAnnexin V-128
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Carotid Stenosis; Carotid Artery Narrowing; Carotid Artery Plaque; Carotid Artery Stenosis; Carotid Artery Ulcerating Plaque; Carotid Ulcer; Common Carotid Artery Stenosis; External Carotid Artery Stenosis; Internal Carotid Artery Stenosis; Plaque, Ulcerating, Carotid Artery; Stenosis, Common Carotid Artery; Stenosis, External Carotid Artery; Ulcerating Plaque, Carotid Artery

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.
    

Eligibility criteria:

        Inclusion Criteria:

        For all participants:

          1. Males and females age 18 years or greater

          2. Able and willing to comply with the study procedures

          3. Negative pregnancy test for women of childbearing potential at screening and on the
             day of administration of 99mTc-rhAnnexin V-128.

             For participants with carotid artery disease:

          4. Evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid
             ultrasound within 2 years;

          5. Evidence of 50% or more carotid stenosis in the most recent US imaging within 8 weeks
             prior to 99mTc-rhAnnexin V-128 administration

             For control participants:

          6. No significant carotid artery disease on carotid ultrasound;

          7. No clinically significant abnormalities in baseline laboratory values.

        Exclusion Criteria:

          1. Previous carotid stending, endarterectomy or stroke;

          2. Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease
             (Ehlers-Danlos, Marfans);

          3. Pregnancy or lactation;

          4. 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;

          5. Know hypersensitivity to the investigational product or any of its components;

          6. Claustrophobia or inability to lie still in a supine position;

          7. 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;

          8. Unwillingness to provide consent.