FAZA PET/MRI in CLI Patients Pre and Post Revascularization

NCT04054609 | Recruiting

• 1 other identifier: 18-6114
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Validation of FAZA PET/MRI as a biomarker of hypoxia

  The change of degree and pattern of 18F-Fluoroazomycin Arabinoside (FAZA) uptake in the PET/MRI scan of limb in patients with critical limb ischemia

  FAZA PET/MRI 2-3 weeks before endovascular treatment and 4-6 weeks after endovascular treatment

Study Arms (1)

FAZA PET/MRI scan

OTHER

PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside

Diagnostic Test: FAZA PET/MRI scan

Interventions

FAZA PET/MRI scan DIAGNOSTIC_TEST

PET/MRI scan using radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) pre and post standard of care endovascular treatment for critical limb ischemia patients

FAZA PET/MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Related Publications (1)

• Farag A, Kohan A, Sekine T, Mirshahvalad SA, Metser U, Mafeld S, Tan K, Veit-Haibach P. Measuring hypoxia in chronic limb-threatening ischemia using 18F-FAZA kinetic modelling - a pilot study. EJNMMI Res. 2025 Apr 26;15(1):48. doi: 10.1186/s13550-025-01243-5.

  PMID: 40287606 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Patrick Veit-Haibach, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Veit-Haibach, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 13, 2019
• Study Start: August 31, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CA (1)