NCT02667457

99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis

99mTc-rhAnnexin V-128 Planar and SPECT Imaging of Apoptosis in Asymptomatic Or Previously Symptomatic With TIA Patients With Carotid Atherosclerotic Plaque

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Advanced Accelerator Applications · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
RADIATION	99mTc-rhAnnexin V-128

Timeline

• Start date: 2016-06-23
• Primary completion: 2018-11-12
• Completion: 2018-11-19
• First posted: 2016-01-29
• Last updated: 2020-10-09
• Results posted: 2020-10-09

Locations

1 site across 1 country: Canada