Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Nationwide Children's Hospital
- Study ID
- NCT03622359
- Status
- Recruiting
Conditions
- Chronic Limb-Threatening Ischemia
- Diabetes Mellitus
- Peripheral Artery Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- SPECT/CT perfusion imaging — DIAGNOSTIC_TESTSubjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
- PET/CT perfusion imaging — DIAGNOSTIC_TESTSubjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Study Details
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.
Key Dates
- Start date
- Feb 17, 2017
- Status verified
- Mar 2025
- Primary completion
- Aug 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 192 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: SPECT/CT perfusion imagingPatients 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.
- Experimental: PET/CT perfusion imagingPatients 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 Measure
Lower extremity perfusion [ Time Frame: 1-2 weeks ]
Central Contacts
- Mitchel R Stacy, Ph.D.614-355-5836
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 |
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