Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

March 12, 2024 updated by: Mitchel Stacy, Nationwide Children's Hospital

Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease

The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PAD patients (n=80) with peripheral artery disease (PAD) who are scheduled to undergo lower extremity revascularization procedures will be recruited. Patients will be screened using a standard medical history questionnaire and a physical activity questionnaire. Once their questionnaires are reviewed, individuals who meet inclusion criteria will proceed with standard PAD screening, which will include Ankle-Brachial Indices (ABIs) and Toe-Brachial Indices (TBIs) of both lower extremities. Patients will undergo SPECT/CT or PET/CT perfusion imaging prior to their revascularization procedure and 1-14 days following revascularization. Subjects will receive an intravenous injection of a standard clinical dose of radiotracer for both imaging sessions. A low-dose CT scan will be performed immediately after each SPECT and PET image acquisition for the purposes of attenuation correction and regional analysis of radiotracer uptake. Clinical outcomes will be evaluated for up to 12 months after the imaging study to assess the prognostic value of perfusion imaging for predicting subsequent outcomes. An additional subset of PAD patients (n=56) and healthy control subjects (n=56) will be enrolled to undergo the same imaging procedures to establish a healthy database for PET perfusion imaging measures.

Study Type

Interventional

Enrollment (Estimated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Patients with Peripheral Artery Disease:

  1. At least 18 years of age
  2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.

Exclusion Criteria for Patients with Peripheral Artery Disease:

  1. Unable to give informed consent or follow-up
  2. Pregnant or nursing
  3. Under the age of 18
  4. No history of peripheral artery disease

Inclusion Criteria for Healthy Control Subjects:

  1. At least 18 years of age
  2. No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.

Exclusion Criteria for Healthy Control Subjects:

  1. Unable to give informed consent of follow-up
  2. Pregnant or nursing
  3. Under the age of 18
  4. History of peripheral artery disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPECT/CT perfusion imaging
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.
Diagnostic test: SPECT/CT perfusion imaging
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Diagnostic test: PET/CT perfusion imaging
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Experimental: PET/CT perfusion imaging
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.
Diagnostic test: SPECT/CT perfusion imaging
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Diagnostic test: PET/CT perfusion imaging
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity perfusion
Time Frame: 1-2 weeks
The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.
1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 1 year
Rates of wound healing will be documented for 12 months following enrollment into the imaging study.
1 year
Limb salvage
Time Frame: 1 year
Amputation rates will be documented for the 12 months following enrollment into the imaging study.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

Ohio State University

Investigators

  • Principal Investigator: Mitchel R Stacy, Ph.D., Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2017

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-00442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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