Evaluation of Prognostic Value of 18F-Fluoroazomycin Arabinoside (FAZA) PET/MRI in Patients with Critical Limb Ischemia Before and After Revascularization: A Pilot Study

What this Trial Is About

Peripheral artery disease is a serious global health issue that can lead to high rates of death and limited mobility. Critical limb ischemia (CLI) is a severe form of this disease that greatly increases the risk of limb amputation and lowers quality of life. Researchers are evaluating a new diagnostic tool using a special radiotracer called 18F-Fluoroazomycin Arabinoside (FAZA) with PET/MR imaging to better detect and measure low oxygen levels in tissue before and after standard endovascular treatments for CLI. This study aims to find imaging markers that could predict treatment outcomes and improve care choices for patients. Participants will undergo PET/MRI scans using the FAZA tracer approximately 2 to 3 weeks before their scheduled endovascular revascularization treatment and again 4 to 6 weeks after the procedure. This imaging method allows detailed assessment of tissue hypoxia in the affected limbs, potentially offering more accurate diagnostic information than traditional tests. The study also includes refining MRI techniques to enhance image quality in CLI patients. During the study, participants will be monitored through these imaging sessions and clinical evaluations to assess how well FAZA PET/MRI works as a biomarker of tissue hypoxia. The main outcome measured is the validation of this imaging approach before and after treatment. Participants must be able to lie still for the scans and provide written consent. The study is led by the University Health Network in Toronto and involves adults with CLI who are candidates for revascularization therapy.

FAZA PET/MRI in CLI Patients Pre and Post Revascularization