Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Not Applicable

Recruiting

• Conditions: Chronic Limb-Threatening Ischemia; Peripheral Artery Disease; Diabetes Mellitus
• Interventions: Diagnostic Test: SPECT/CT perfusion imaging; Diagnostic Test: PET/CT perfusion imaging

• Registration Number: NCT03622359
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-01
• Primary Completion: 2028-08-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPECT/CT perfusion imaging	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.
SPECT/CT perfusion imaging	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 SPECT/CT imaging as part of the research protocol.
PET/CT perfusion imaging	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.
PET/CT perfusion imaging	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 PET/CT imaging as part of the research protocol.

Primary Outcome Measures

Name	Time	Method
Lower extremity perfusion	1-2 weeks	The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Wound healing	1 year	Rates of wound healing will be documented for 12 months following enrollment into the imaging study.
Limb salvage	1 year	Amputation rates will be documented for the 12 months following enrollment into the imaging study.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States