Evolution of Succinate Accumulation Detected in Vivo by Spectroscopic Magnetic Resonance Imaging (1H-SRM) After External Beam Radiation Therapy in SDHx-mutated Patients With Cervical Paragangliomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Disappearance of succinate accumulation at M12
研究概览
简要总结
Qualitative and quantitative biomarker of response to radiotherapy is needed in paragangliomas. We aim at assessing the added value of 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.
详细描述
Paragangliomas (PGL) are rare neuroendocrine tumors inherited in 40% of cases. SDHx genes (SDHA, SDHB, SDHC, SDHD), encoding the 4 subunits of the mitochondrial enzyme succinate dehydrogenase (SDH), are the most frequently involved.
Accumulation of succinate, the substrate for SDH, is a very specific biomarker for these mutations. Recently, we have demonstrated the feasability of detecting and quantifying succinate in tumors in vivo, by magnetic resonance spectroscopy (1H-SRM).
Patients carrying these mutations frequently develop cervical PGL for which the treatment of choice is external beam radiation therapy (EBR).
The objective of this project is to determine the feasibility of using 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.
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
- •Signed informed consent
- •Patient with cervical PGL with planning of treatment with EBR
- •Patient with an SDHx mutation or unknown genetic status
- •Patient affiliated to a social security scheme
排除标准
- •Pregnant woman
- •Contraindication to MRI (implantable device, etc.)
- •Impossibility of lying down without movement for 45 minutes (hyperalgesic patient, claustrophobia, etc.)
- •PPGL having previously been the subject of local (excluding surgery) or systemic treatment
- •PPGL <1 cm longest axis
- •Patient under guardianship or curatorship
结局指标
主要结局
Disappearance of succinate accumulation at M12
时间窗: 12 months
Absence of succinate accumulation detected in vivo by 1H-SRM, in cervical PGLs with SDHx mutations, at 12 months after EBR, reviewed by 2 independant experts blinded to all other clinical and genetics data.
次要结局
- Performance of PET/CT at M12 after EBR(12 months)
- Metastatic evolution or death at M12(12 months)
- Disapperance of succinate accumulation at M3(3 months)
- Performance of cervical MRI at M3 and M12 after EBR(12 months)