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NCT Number: NCT04054609

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Validation of FAZA PET/MRI as a biomarker of hypoxia

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Veit-Haibach, MD

CONTACT

[email protected]

416-340-4800 ext. 6085

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2019
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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