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FAZA PET/MRI in CLI Patients Pre and Post 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04054609
Enrollment
40
Registered
2019-08-13
Start date
2019-08-31
Completion date
2027-12-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

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.

Interventions

DIAGNOSTIC_TESTFAZA 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

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

FAZA PET/MRI scan pre and post standard of care endovascular treatment for critical limb ischemia patients

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Validation of FAZA PET/MRI as a biomarker of hypoxiaFAZA PET/MRI 2-3 weeks before endovascular treatment and 4-6 weeks after endovascular treatmentThe change of degree and pattern of 18F-Fluoroazomycin Arabinoside (FAZA) uptake in the PET/MRI scan of limb in patients with critical limb ischemia

Countries

Canada

Contacts

CONTACTPatrick Veit-Haibach, MD
Patrick.Veit-Haibach@uhn.ca416-340-4800
PRINCIPAL_INVESTIGATORPatrick Veit-Haibach, MD

University Health Network, Toronto

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026