FAZA PET/MRI in CLI Patients Pre and Post Revascularization

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University Health Network, Toronto

临床试验: NCT04054609

BioSeek: nct04054609

关键词

抽象

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.

日期

最后验证:	06/30/2019
首次提交:	07/31/2019
提交的预估入学人数:	08/11/2019
首次发布:	08/12/2019
上次提交的更新:	08/11/2019
最近更新发布:	08/12/2019
实际学习开始日期:	07/31/2019
预计主要完成日期:	11/30/2021
预计完成日期:	11/30/2022

状况或疾病

Critical Limb Ischemia

干预/治疗

Diagnostic Test: FAZA PET/MRI scan

相

手臂组

臂	干预/治疗
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

资格标准

有资格学习的年龄	18 Years 至 18 Years
有资格学习的性别	All
接受健康志愿者	是
标准	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.

结果

主要结果指标

1. Validation of FAZA PET/MRI as a biomarker of hypoxia [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

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

关键词

hypoxia

ischemia

peripheral arterial disease

arabinoside

抽象

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

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