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FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Primary Purpose

Critical Limb Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FAZA PET/MRI scan
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Critical Limb Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FAZA PET/MRI scan

Arm Description

PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 1, 2019
Last Updated
November 9, 2020
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04054609
Brief Title
FAZA PET/MRI in CLI Patients Pre and Post Revascularization
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
FAZA PET/MRI scan pre and post standard of care endovascular treatment for critical limb ischemia patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAZA PET/MRI scan
Arm Type
Other
Arm Description
PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside
Intervention Type
Diagnostic Test
Intervention Name(s)
FAZA PET/MRI scan
Intervention Description
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 Measure Information:
Title
Validation of FAZA PET/MRI as a biomarker of hypoxia
Description
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
Time Frame
FAZA PET/MRI 2-3 weeks before endovascular treatment and 4-6 weeks after endovascular treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Veit-Haibach, MD
Phone
416-340-4800
Ext
6085
Email
Patrick.Veit-Haibach@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Veit-Haibach, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

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FAZA PET/MRI in CLI Patients Pre and Post Revascularization

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