Study of FAZA PETMRI Scans Before and After Revascularization in Adults with Critical Limb Ischemia

What this Trial Is About

Peripheral artery disease is a global health issue that often leads to serious complications such as critical limb ischemia CLI, which carries a high risk of amputation and decreased quality of life. This study evaluates the use of a novel molecular imaging tool, the radiotracer 18F-Fluoroazomycin Arabinoside FAZA, in PETMRI scans to better assess tissue hypoxia in patients with CLI before and after endovascular revascularization treatment. The study aims to improve diagnostic accuracy and identify predictors of treatment outcomes. Participants will undergo FAZA PETMRI scans approximately 2 to 3 weeks before and 4 to 6 weeks after receiving standard endovascular treatment to restore blood flow in affected limbs. This imaging technique allows detailed evaluation of the location and severity of tissue hypoxia in the extremities. The study also includes post-processing optimization of MRI sequences to enhance imaging quality. All interventions focus on diagnostic assessment rather than therapeutic treatment. Throughout the study, participants will be monitored using PETMRI scans to validate FAZA as a biomarker of tissue hypoxia related to CLI. Researchers will analyze imaging results to develop models predicting patient outcomes after revascularization. Participants will provide informed consent and undergo pregnancy testing if applicable. The total duration of participation includes imaging before and after treatment, with safety and diagnostic assessments recorded throughout the study period ending in December 2027.

FAZA PET/MRI in CLI Patients Pre and Post Revascularization