Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

NCT03590769 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 16-21018
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Peripheral Arterial Disease; PAD; Claudication, Intermittent; Claudication; SFA Occlusion; Arterial Occlusion; Iliac Artery Occlusion; Vascular Calcification

Outcome Measures

Primary Outcomes (1)

• Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.

  Patient is given 18F-FDG radio tracer. The tracer is quantitatively measured through FDG-PET imaging modality for uptake at the intervention site.

  1 time each week for 3 weeks

Secondary Outcomes (1)

• Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury.

  1 time each week for 3 weeks

Study Arms (1)

PET/MR using FDG-18 radiotracer

EXPERIMENTAL

Using FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer.

Drug: 18F-FDG

Interventions

18F-FDG DRUG

All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG

PET/MR using FDG-18 radiotracer

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, or stenting of the iliac artery or SFA.

You may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Vascular Calcification; Arterial Occlusive Diseases

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Michael S Conte, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Miguel H Pampaloni, M.D., PhD.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient undergoing percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA, will have 18F-FDG-PET scan at the region of interest before intervention, then post-operatively 1 day and 1 week from treatment.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: July 18, 2018
• Study Start: June 1, 2017
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)