99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02667457
• Date of registration: 26/01/2016
• Prospective Registration: Yes
• Primary sponsor: Advanced Accelerator Applications
• Public title: 99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
• Scientific title: 99mTc-rhAnnexin V-128 Planar and SPECT Imaging of Apoptosis in Asymptomatic Or Previously Symptomatic With TIA Patients With Carotid Atherosclerotic Plaque
• Date of first enrolment: June 23, 2016
• Target sample size: 39
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02667457
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carotid Artery Plaque

Intervention(s)

Radiation: 99mTc-rhAnnexin V-128

Primary Outcome(s)

Percentage of Participants With Prevalence of Abnormal 99mTc-rhAnnexin V-128 SPECT/CT Imaging (Phase II Step) [Time Frame: At 60 and 120 minutes post injection on Day 0]

Number of Participants Evaluated for Imaging Feasibility [Time Frame: Day 0]

Secondary Outcome(s)

Left Carotid Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR) [Time Frame: At 60 and 120 minutes post injection on Day 0]

Aortic Arch Uptake Correlation Imaging Assessment as Measured by Target to Background Ratio (TBR) [Time Frame: At 60 and 120 minutes post injection on Day 0]

Descending Aorta Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR) [Time Frame: At 60 and 120 minutes post injection on Day 0]

Number of Participants With Clinically Significant Abnormal Laboratory Values [Time Frame: From Day 0 post injection up to Day 30]

Ascending Aorta Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR) [Time Frame: At 60 and 120 minutes post injection on Day 0]

Right Carotid Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR) [Time Frame: At 60 and 120 minutes post injection on Day 0]

Left Carotid Uptake Imaging Assessment as Measure by Target to Background Ratio (TBR) by Ultrasound Grade of Plaque Echolucency/Echogenicity [Time Frame: At 60 and 120 minutes post injection on Day 0]

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and Death [Time Frame: From Day 0 post injection up to Day 30]

Right Carotid Uptake Imaging Assessment as Measure by Target to Background Ratio (TBR) by Ultrasound Grade of Plaque Echolucency/Echogenicity [Time Frame: At 60 and 120 minutes post injection on Day 0]

Secondary ID(s)

AAA-Annexin-04

CAAA113A32201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02667457