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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Diagnostic test: FAZA PET/MRI scan

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Veit-Haibach, MD; Phone Number: 6085 416-340-4800; Email: Patrick.Veit-Haibach@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Recruiting
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FAZA PET/MRI scan; PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside	Diagnostic test: FAZA 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Patrick Veit-Haibach, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Ischemia
• Other Study ID Numbers: 18-6114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No