RecruitingNot ApplicableNCT04054609

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Evaluation Of Prognostic Value of 18f-Fluoroazomycin Arabinoside (FAZA) Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR) In Patients With Critical Limb Ischemia Pre- and Post Revascularization: a Pilot Study


Sponsor

University Health Network, Toronto

Enrollment

40 participants

Start Date

Aug 31, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Peripheral artery disease is a worldwide problem, leading to high mortality and mobility. Critical limb ischemia (CLI) is associated with high risk of amputation with the subsequent decreased in life quality. Endovascular therapy is now considered the primary treatment option in these patients to improve the vascularity and prevent amputations. In recent years, development of molecular imaging tools are now become available. A recent radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) its an specific marker of hypoxia in the tissues and has been used in multiples studies. This tracer can be used in PET/MR scan providing a potentially power diagnostic tool in patients with CLI, allowing in one diagnostic study the evaluation of location and degree of hypoxia in the extremity tissues. This diagnostic tool may offer a better assessment pre and post standard of care endovascular treatment for the patients. Moreover, some of the patients treated with endovascular therapy may not have a favorable outcome, without a clear reason explaining this situation. We will try to find some predictor model in the FAZA PET/MR that can explain the different outcomes and may help clinicians choose the best treatment option in specific cases. Thirdly, post processing for optimization of the MR sequences in patients with CLI will be performed at the MR component of the PET. There would thus be great clinical interest in developing non-invasive tools that could provide more accurate diagnostic information compared to traditional tests for these patients population.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

Critical limb ischemia (CLI) is a severe form of poor blood flow to the legs, often causing pain at rest, wounds that won't heal, or gangrene. This study uses a special type of PET/MRI imaging with a tracer called FAZA to measure how much oxygen the tissue in the legs is receiving before and after a procedure to restore blood flow (revascularization). The goal is to see if this imaging can predict who will benefit most from treatment. Participants must be adults with CLI who are candidates for revascularization treatment. The study excludes people who cannot have an MRI, are pregnant or breastfeeding, have metallic hardware in the lower limbs, cannot tolerate ethanol, or face imminent amputation within 6 weeks. You may be eligible if: - You are 18 years or older - You have been diagnosed with critical limb ischemia - You are a candidate for revascularization (a procedure to restore blood flow) - You are able to lie flat for at least 30 minutes - You can provide written informed consent You may NOT be eligible if: - You have a contraindication to MRI (such as a pacemaker or metal implants) - You are pregnant or breastfeeding - You have metallic hardware in your lower limbs - You are unable or unwilling to provide informed consent - You are facing amputation within the next 6 weeks - You cannot tolerate ethanol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFAZA PET/MRI scan

PET/MRI scan using radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) pre and post standard of care endovascular treatment for critical limb ischemia patients


Locations(1)

University Health Network

Toronto, Ontario, Canada

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NCT04054609


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