FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • FAZA PET/MRI scan

    Diagnostic test

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: FAZA PET/MRI scanOther 1 intervention

Trial outcomes

Primary outcomes

1

Validation of FAZA PET/MRI as a biomarker of hypoxia

The change of degree and pattern of 18F-Fluoroazomycin Arabinoside (FAZA) uptake in the PET/MRI scan of limb in patients with critical limb ischemia

Time frame
FAZA PET/MRI 2-3 weeks before endovascular treatment and 4-6 weeks after endovascular treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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