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临床试验/NCT04054609
NCT04054609招募中不适用

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

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Validation of FAZA PET/MRI as a biomarker of hypoxia

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

FAZA PET/MRI scan

Other

PET/MRI scan using radiotracer 18F-Fluoroazomycin Arabinoside

干预措施: FAZA PET/MRI scan (Diagnostic Test)

结局指标

主要结局

Validation of FAZA PET/MRI as a biomarker of hypoxia

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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