Summary

for people ages 40 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Michael S Conte Miguel H Pampaloni

Description

Summary

This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery or popliteal artery 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.

Details

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.

Keywords

Peripheral Arterial Disease Claudication, Intermittent Claudication PAD SFA - Superficial Femoral Artery Stenosis Iliac Artery Disease Vascular Calcification SFA Occlusion Arterial Occlusion Iliac Artery Occlusion Inflammation Peripheral Vascular Diseases Intermittent Claudication Calcinosis 18F-FDG PET/MR using FDG-18 radiotracer

Eligibility

You can join if…

Open to people ages 40 years and up

  • Over the age of 40,
  • With resting or exercise ABI <0.9, TBI <0.6
  • Have claudication or limb threatening ischemia & planning to undergo a percutaneous angioplasty of SFA or popliteal artery.

You CAN'T join if...

  • Evidence of active infection
  • Hypersensitivity or allergy to contrast agents
  • Chronic liver disease, renal disease (GFR< 30) or chronic inflammatory disorders
  • Insulin dependent diabetes
  • Presence of metal within subject's body, pacemakers, or defibrillators
  • BMI < 20 or >35
  • Recent other major surgery or illness within 30 days
  • Use of immunosuppressive medications or steroids
  • History of organ transplantation
  • Pregnancy, or plans to become pregnant, or lactating

Locations

  • San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States
  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientists

  • Michael S Conte
  • Miguel H Pampaloni
    Miguel Hernandez Pampaloni, MD, PhD, is an Associate Professor in Residence and Chief of Nuclear Medicine in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. Dr. Pampaloni is responsible for all clinical administrative coordination, performance and supervision within the section.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03590769
Phase
Phase 1
Study Type
Interventional
Last Updated