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Clinical Trials in Canada / NCT04054609
Recruiting Not applicable

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

NCT04054609 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2019-08-31
Last updated
2026-06-10

Condition(s) studied

Critical Limb Ischemia

Investigational drug(s) / intervention(s)

FAZA PET/MRI scan

FAZA 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \>= 18 years; * Patients with clinical evidence of critical limb ischemia that are candidates for revascularization treatment; * A negative urine or serum pregnancy test in women of child-bearing age; * Ability to provide written informed consent to participate in the study. Exclusion Criteria: * Contraindication for MR as per current institutional guidelines; * Inability to lie supine for at least 30 minutes; * Pregnant or breastfeeding; * Unable or unwilling to provide informed consent; * Impending amputation within 6 weeks of presentation; * Previous metallic hardware in the lower limbs; * Unable to have ethanol.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Health Network Toronto Ontario Recruiting

More University Health Network, Toronto trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04054609 on ClinicalTrials.gov ↗ ← All trials in Canada