Recruiting

FAZA PET/MRI

Sponsor:

University Health Network, Toronto

Code:

NCT04054609

Conditions

Critical Limb Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FAZA PET/MRI scan

Study Details

Brief 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.

Conditions

Critical Limb Ischemia

Study ID

NCT04054609

Start date

Aug 31, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: FAZA PET/MRI scan

PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Patrick Veit-Haibach, MD

416-340-4800Patrick.Veit-Haibach@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-10.