NCT03590769

Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.

Detailed description

Magnetic resonance imaging (MRI) imaging allows for non-invasive visualization of anatomical structures while Positron emission tomography (PET) scans allow for the observation of molecular and cellular activities. Using a PET/MRI in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo. Acute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. Macrophages are very metabolically active and consume glucose at a high rate. In PET/MRI, subjects are injected with 18F-Fluorodeoxyglucose (18F-FDG), a radioactively labeled glucose molecule which is consumed by macrophages. When 18F-FDG is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. Thus, FDG-PET provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site. This study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.

Conditions

• Peripheral Arterial Disease
• Claudication, Intermittent
• Claudication
• PAD
• SFA - Superficial Femoral Artery Stenosis
• Iliac Artery Disease
• Vascular Calcification

Interventions

Type	Name	Description
DRUG	18F-FDG	All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-09-03
• Completion: 2019-09-03
• First posted: 2018-07-18
• Last updated: 2020-11-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study