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
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Patrick Veit-Haibach, MD
Patrick.Veit-Haibach@uhn.ca
416-340-4800
Time Frame
Start Date: 2019-08-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
Other: FAZA PET/MRI scan
PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov