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临床试验/NCT03716986
NCT03716986Unknown不适用

Multimodal Imaging of Hypoxia in Gliomas

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
MRI tissue oxygenation map (SatO2-MRI) validation

研究概览

简要总结

The imaging of cerebral oxygenation is an extremely important tool in understanding the pathophysiology of the tumor and for adaptation of therapies according to hypoxia. Currently, imaging of cerebral oxygenation is mainly performed by the use of Positron Emission Tomography (PET). Thus, the investigators have been able to show that the FMISO radiotracer can reveal tumor hypoxia (HypOnco study, promotor: Caen University Hospital, main investigator: J.S. Guillamo). After injection of the radiotracer, increased uptake is observed in the regions for which the tissue oxygen pressure is less than 10 mmHg (the healthy brain with a tissue oxygen pressure (ptO2) ≈ 40mmHg).

Although PET is a reference methodology, it is not widely practiced mainly because of radioactive sources. Magnetic Resonance Imaging (MRI) would bypass the previously mentioned PET limitations. The investigators have recently shown that a measure of local oxygen saturation could be obtained by MRI.

This methodology has also been implemented at a clinical scale on lower field MRI magnets, but its formal validation in a clinical situation remains to be demonstrated with respect to FMISO.

The major advantage of this methodology is that MRI is already performed in routine practice for patients. Measuring tissue oxygenation with MRI (SatO2-MRI) would not add additional examination for the patient. In addition, MRI is a non-ionizing methodology with a very good spatial resolution compared to PET, this should help to better understand intratumoral heterogeneity. Similarly, in preclinical studies, the investigators have shown in a context of mild hypoxia that SatO2-MRI may be more sensitive than PET.

The investigators propose a study to compare in patients with glial tumors, images obtained by 3 Tesla MRI of SatO2-MRI to the hypoxia maps obtained by FMISO PET. These imaging studies will be confronted with studies carried out in immunohistochemistry on biopsies / resection allowing to reveal and to quantify by image analysis the expression of the factors induced by hypoxia (HIF1, HIF2).

This study should include 20 patients with glioma (15 high-grade patients and 5 low-grade patients) in pre-surgery. The aim is to show that SatO2-MRI is a relevant methodology (in terms of sensitivity, specificity) for assessing intratumoral oxygenation in a context of brain tumors. This fits perfectly into an era of personalized medicine where functional imaging finds its meaning.

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

入选标准

  • Adult patient (> 18 years-old)
  • Patient with a diffuse glioma (astrocytoma or oligodendroglioma or glioblastoma)
  • Karnofsky index ≥ 70%
  • Patient able to understand and sign the consent or accompanied by a trusted person who can do so
  • Normal blood test with results: neutrophil ≥ 1500 cells / μl, platelets ≥ 100,000 μl, serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5 x upper normal limit (UNL), creatine ≤ 1.5 x UNL
  • Patient affiliated to a social security

排除标准

  • Patient with contraindications to surgery

研究组 & 干预措施

SatO2

Other

干预措施: MRI Oxygen Saturation Map (Diagnostic Test)

结局指标

主要结局

MRI tissue oxygenation map (SatO2-MRI) validation

时间窗: 7 days

Validation of SatO2-MRI as a reliable imaging method to detect hypoxic regions, in comparison with FMISO PET. This will mainly be done by measuring spatial correlation of hypoxic regions obtained by the two imaging modalities.

次要结局

  • Comparison with pathologic studies(7 to 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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