Critical Limb IschemiaNCT04054609
FAZA PET/MRI in CLI Patients Pre and Post Revascularization
A study testing FAZA PET/MRI scan in people with Critical Limb Ischemia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- FAZA PET/MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2019to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2N2
About this study
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
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.
Read more
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
- Being tested
- FAZA PET/MRI scan
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAZA PET/MRI scanDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| FAZA PET/MRI scan | Other | PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside Receives: Diagnostic Test: FAZA PET/MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: FAZA PET/MRI 2-3 weeks before endovascular treatment and 4-6 weeks after endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start31 Aug 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- FAZA PET/MRI scan pre and post standard of care endovascular treatment for critical limb ischemia patients
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054609
- Sponsor's protocol ID
- 18-6114
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40287606
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04054609
- Acronym / sponsor ID
- 18-6114
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- FAZA PET/MRI scan pre and post standard of care endovascular treatment for critical limb ischemia patients
| Arm | Type | Receives |
|---|---|---|
| FAZA PET/MRI scan | Other | Diagnostic Test: FAZA PET/MRI scanPET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAZA PET/MRI scanPET/MRI scan using radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) pre and post standard of care endovascular treatment for critical limb ischemia patients | Diagnostic test | FAZA PET/MRI scan |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 40287606Farag 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.
Related trials for Critical Limb Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
RecruitingEarly Phase 1
Nutrition in Patient With Critical Limb Ischemia
Critical Limb Ischemia, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Veit-Haibach, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAZA PET/MRI scan in people with Critical Limb Ischemia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Veit-Haibach, MD (416-340-4800 ext. 6085, Patrick.Veit-Haibach@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04054609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.