Non Invasive IDentification of Gliomas With IDH1/2 Mutation by Analysis of Circulating Plasmatic DNA, D-2-hydroxyglutarate Dosage in Biological Liquids and Detection by Brain SPEctro-MRI: Impact for Diagnosis and Follow-up
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- D-2HG quantified by spectroMRI the measure of the ratio between two pics D-2HG and creatine [Time Frame: 3 months after surgery] [Designated as safety issue: No]
研究概览
简要总结
This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.
In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.
In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.
详细描述
The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.
The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).
The secondary endpoints include:
- longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
- Differentiation of tumor recurrence from radiation induced changes
- Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction
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
- •Affiliation to a social security system
- •Patient≥ 18 years old
- •Written informed consent
- •One of the two situations:
- •presumed grade II-III glioma candidate to surgery (group 1)
- •IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)
- •Evaluable tumoral mass min diameter >2 cm (FLAIR)
排除标准
- •Contra-indication to MRI
- •Patient unable to give an written Informed Consent
- •Patient under guardianship or deprived of freedom
- •For group 2: patient already included in group 1
研究组 & 干预措施
IDH1/IDH2
干预措施: Spectro-MRI (Radiation)
IDH1/IDH2
干预措施: Dosage of free circulating plasmatic DNA (Other)
IDH1/IDH2
干预措施: Dosage of D-2HG in the urine (Other)
结局指标
主要结局
D-2HG quantified by spectroMRI the measure of the ratio between two pics D-2HG and creatine [Time Frame: 3 months after surgery] [Designated as safety issue: No]
时间窗: 3 months after surgery
This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery
次要结局
- SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No](evolution over 12 months)