Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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The aim of this clinical study is to assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in diabetic patients with peripheral arterial 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 assessing regional abnormalities in foot/calf muscle perfusion and evaluating treatment responses.

Detailed Description
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PAD patients (n=200) with peripheral arterial 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.

Official Title
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Radiotracer-Based Imaging for Quantitative Assessment of Angiosome Perfusion Following Lower Extremity Revascularization

Conditions
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Peripheral Arterial Disease, Diabetes Mellitus, Critical Limb Ischemia

Intervention / Treatment
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* Diagnostic Test: SPECT/CT perfusion imaging
* Diagnostic Test: PET/CT perfusion imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age 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: Unable to give informed consent or follow-up Pregnant or nursing Under the age of 18 No history of peripheral arterial disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPECT/CT perfusion imaging<br>Patients with peripheral arterial 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<br>* Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.<br>Diagnostic Test: PET/CT perfusion imaging<br>* Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.<br>|
| Experimental: PET/CT perfusion imaging<br>Patients with peripheral arterial 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<br>* Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.<br>Diagnostic Test: PET/CT perfusion imaging<br>* Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radionuclide imaging, Perfusion imaging