Using FAZA PET/MRI to assess critical limb ischemia before and after revascularization
Official 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
Run by University Health Network, Toronto · NCT04054609 · Data updated 2026-11-12
This study is testing a new imaging tool to see how well it can help doctors understand and treat people with critical limb ischemia before and after they have surgery to improve blood flow.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | August 31, 2019 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT04054609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with clinical evidence of critical limb ischemia who are eligible for revascularization treatment.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have impending amputation within 6 weeks may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the use of a novel imaging tool, FAZA PET/MRI, to assess patients with critical limb ischemia (CLI) before and after they undergo revascularization treatment. The study aims to determine the location and degree of tissue hypoxia in the extremities, which is crucial for understanding the effectiveness of the endovascular therapy. By utilizing this advanced imaging technique, the trial seeks to improve diagnostic capabilities and patient outcomes in those suffering from CLI. Participants will be monitored for changes in their condition as a result of the intervention.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic assessment and treatment outcomes for patients with critical limb ischemia.
How similar studies have gone: While the use of FAZA as a hypoxia marker is promising, this specific application in CLI patients is novel and has not been extensively tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University Health Network
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Patrick Veit-Haibach, MD — University Health Network, Toronto
- Study coordinator: Patrick Veit-Haibach, MD
- Email: Patrick.Veit-Haibach@uhn.ca
- Phone: 416-340-4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.