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FAZA PET/MRI in CLI Patients Pre and Post Revascularization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04054609
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Diagnostic Test: FAZA PET/MRI scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: FAZA PET/MRI scan pre and post standard of care endovascular treatment for critical limb ischemia patients
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Validation of FAZA PET/MRI as a biomarker of hypoxia [ Time Frame: FAZA PET/MRI 2-3 weeks before endovascular treatment and 4-6 weeks after endovascular treatment ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04054609

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Contact: Patrick Veit-Haibach, MD 416-340-4800 ext 6085

Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Patrick Veit-Haibach, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT04054609     History of Changes
Other Study ID Numbers: 18-6114
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pathologic Processes
Fluoroazomycin arabinoside
Molecular Mechanisms of Pharmacological Action