99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis

Advanced Accelerator Applications

Status and phase: Terminated; Phase 2

Conditions: Carotid Artery Plaque

Treatments: Radiation: 99mTc-rhAnnexin V-128

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667457

AAA-Annexin-04

CAAA113A32201 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

CAD Participants

Experimental group

Description:

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).

Treatment:

Radiation: 99mTc-rhAnnexin V-128

Healthy Participants

Experimental group

Description:

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).

Treatment:

Radiation: 99mTc-rhAnnexin V-128