Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04054609

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Led by University Health Network, Toronto · Updated on 2025-03-30

40

Participants Needed

1

Research Sites

326 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3e= 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Health Network

Toronto, Ontario, Canada, M5G 2N2

Actively Recruiting

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Research Team

P

Patrick Veit-Haibach, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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FAZA PET/MRI in CLI Patients Pre and Post Revascularization | DecenTrialz