Clinical Applications for Radiotracer Imaging of Lower Extremity Peripheral Arterial Disease and Critical Limb Ischemia.
Ting-Heng Chou, Mitchel R Stacy
https://pubmed.ncbi.nlm.nih.gov/31482412Actively Recruiting
Led by Nationwide Children's Hospital · Updated on 2025-04-01
192
Participants Needed
1
Research Sites
17 weeks
Total Duration
N
Nationwide Children's Hospital
Lead Sponsor
O
Ohio State University
Collaborating Sponsor
This research aims to create a healthy database for nuclear perfusion imaging of the lower legs and to evaluate how well radiotracer-based imaging predicts clinical outcomes in patients with peripheral artery disease (PAD) undergoing lower leg revascularization. The study tests whether this imaging method can sensitively detect regional blood flow problems in leg muscles and monitor responses to treatment. Patients with PAD scheduled for revascularization will receive two types of imaging: SPECT/CT or PET/CT perfusion scans. Each patient will get an intravenous injection of a radiotracer before and 1 to 14 days after their procedure. A low-dose CT scan will follow each imaging session for better image analysis. Additionally, a group of PAD patients and healthy volunteers will undergo the same imaging to help build a healthy reference database. Participants will complete medical and physical activity questionnaires, standard PAD screenings including Ankle-Brachial and Toe-Brachial Indices, and imaging sessions before and shortly after their revascularization. Researchers will monitor clinical outcomes such as wound healing and limb salvage for up to 12 months. The main measure is blood flow in the lower legs within 1 to 2 weeks after treatment, with ongoing safety and outcome tracking throughout the study period.
CONDITIONS
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical history and physical activity questionnaires and standard PAD screening including Ankle-Brachial and Toe-Brachial Indices
Duration - 1 to 2 weeks
Participants undergo SPECT/CT or PET/CT perfusion imaging before and after their scheduled lower extremity revascularization procedure.
2 imaging visits (in-person): one prior to revascularization and one 1 to 14 days post-procedure
Duration - Up to 12 months
Participants are followed for clinical outcomes including wound healing and limb salvage for up to 12 months after imaging.
Follow-up assessments occur periodically over 12 months to evaluate clinical outcomes
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
M
Mitchel R Stacy, Ph.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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