Clinical trial NCT02667457: 99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
Official title: 99mTc-rhAnnexin V-128 Planar and SPECT Imaging of Apoptosis in Asymptomatic Or Previously Symptomatic With TIA Patients With Carotid Atherosclerotic Plaque
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carotid Artery Plaque
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
Lead sponsor: Advanced Accelerator Applications
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: The sponsor decided to terminate the study earlier than planned due to strategic decisions to focus the AAA development portfolio on oncology theragnostics and not based on safety concerns. Novartis acquired Advanced Accelerator Applications SA.

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.

Primary outcomes:
measure: Number of Participants Evaluated for Imaging Feasibility
timeFrame: Day 0
measure: 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
Secondary outcomes:
measure: Left Carotid Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)
timeFrame: At 60 and 120 minutes post injection on Day 0
measure: Right Carotid Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)
timeFrame: At 60 and 120 minutes post injection on Day 0
measure: Ascending Aorta Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)
timeFrame: At 60 and 120 minutes post injection on Day 0
measure: Descending Aorta Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)
timeFrame: At 60 and 120 minutes post injection on Day 0
measure: Aortic Arch Uptake Correlation Imaging Assessment as Measured by Target to Background Ratio (TBR)
timeFrame: At 60 and 120 minutes post injection on Day 0
measure: Left Carotid Uptake Imaging Assessment as Measure by Target to Background Ratio (TBR) by Ultrasound Grade of Plaque Echolucency/Echogenicity
timeFrame: At 60 and 120 minutes post injection on Day 0
measure: Right Carotid Uptake Imaging Assessment as Measure by Target to Background Ratio (TBR) by Ultrasound Grade of Plaque Echolucency/Echogenicity
timeFrame: At 60 and 120 minutes post injection on Day 0
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and Death
timeFrame: From Day 0 post injection up to Day 30
measure: Number of Participants With Clinically Significant Abnormal Laboratory Values
timeFrame: From Day 0 post injection up to Day 30
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: