NCT04054609 FAZA PET/MRI in CLI Patients Pre and Post Revascularization
| NCT ID | NCT04054609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Critical Limb Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-08-31 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2019-08-31 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Patrick Veit-Haibach, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT04054609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Limb Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04054609 currently recruiting?
Yes, NCT04054609 is actively recruiting participants. Contact the research team at Patrick.Veit-Haibach@uhn.ca for enrollment information.
Where is the NCT04054609 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04054609 clinical trial?
NCT04054609 is sponsored by University Health Network, Toronto. The principal investigator is Patrick Veit-Haibach, MD at University Health Network, Toronto. The trial plans to enroll 40 participants.