99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis

NCT ID: NCT02667457

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-23
• Study Completion Date: 2018-11-19

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.

Conditions

Carotid Artery Plaque

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CAD Participants

Participants with asymptomatic or previously symptomatic with TIA only carotid atherosclerotic plaque with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an intraveneous (IV) catheter in an antecubital vein, followed by a saline flush on screening (Day 0).

Group Type: EXPERIMENTAL

99mTc-rhAnnexin V-128

Intervention Type: RADIATION

Healthy Participants

Healthy participants with no significant carotid artery disease on carotid ultrasound, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on screening (Day 0).

Group Type: EXPERIMENTAL

99mTc-rhAnnexin V-128

Intervention Type: RADIATION

Interventions

99mTc-rhAnnexin V-128

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Advanced Accelerator Applications

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CAAA113A32201

Identifier Type: OTHER

Identifier Source: secondary_id

AAA-Annexin-04

Identifier Type: -

Identifier Source: org_study_id