Using FAZA PET/MRI to assess critical limb ischemia before and after revascularization
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04054609 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or have impending amputation within 6 weeks may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.