Non Invasive Methods for Differential Diagnosis Radionecrosis/Recurrence After Radiosurgery of Brain Metastases. CV-METANEC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- lesional tissue / normal tissue ratio at PET with FET
研究概览
简要总结
The purpose of this multicenter study is to assess a diagnostic strategy concerning differential diagnosis between radiation necrosis and relapse in brain metastases treated with radiosurgery. Two non-invasive tests - positron emission tomography (PET) with 1F-fluoro-ethyl-tyrosine (FET) and magnetic resonance spectroscopy (MRS) - will be compared to histology in a cohort of patients presenting growing lesions 6 months after radiosurgical treatment.
The results of this study should help to earlier diagnosis of recurrences after radiosurgery and to perform an appropriate treatment for patients.
详细描述
The purpose of the study is to assess a diagnostic strategy by monitoring brain metastases after radio surgical treatment . Data from two non-invasive techniques: PET-FET (positron emission tomography using 1-Fluoro-Ethyl-Tyrosine) and MSR (magnetic resonance spectroscopy) will be compared to histological examination (gold standard) in patients with active persistent and increased lesion 4 months after radiosurgery. The study should develop a decision-making algorithm based on non-invasive tests and allow improving the length and quality of life of these patients.
Early differential diagnosis between relapse and radio necrosis after radiosurgery would allow:
- To perform resection of tumor relapse
- To treat feasable/inoperable tumor relapse with a salvage radiosurgery
- To avoid irradiation for patients presenting radiation necrosis
- To reduce the corticosteroid prescription period. Validation of non-invasive diagnostic tools should in fine avoid biopsy. In addition, the results of this study should help to better estimate the true incidence of radiation necrosis and better specify the predictors of this complication.
CV-METANEC is a prospective, multicenter, open, multidisciplinary study involving the following departments: neurosurgery, neuroradiology, nuclear medicine and neuropathology.
4 centers participating in the study: Groupe Hospitalier Pitié-Salpêtrière University Hospital, Lariboisière Hospital, Lille University Hospital of Clermont Ferrand and Toulouse University Hospital.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years.
- •Patient treated with radiosurgery for one or more brain metastases Free -Intervally between radiosurgical treatment and inclusion in the study at least four months.
- •Lesion (S) treated (s) and followed (s) with the criteria for a clinically active lesion (progressive deficit, seizures, intracranial hypertension steroid-dependent) and / or MRI (increased volume of contrast enhancement with peri-lesional edema and mass effect on two successive examinations at 1 month interval).
- •Karnofsky index>
- •Prognostic compatible for survival with a follow-up at least three months from the date of inclusion.
- •Effective contraception for women of childbearing potential or negative pregnancy test within 72 hours.
- •Signed informed consent obtain
- •Affiliation to the social security system
排除标准
- •Contraindication to MRI examination
- •Clearance of the creatinine incompatible with the injection of gadolinium
- •No potential follow-up in middle or long term
- •Pregnancy
结局指标
主要结局
lesional tissue / normal tissue ratio at PET with FET
时间窗: Day 30
the lipid / lactate ratio at MR spectroscopy
时间窗: Day 30
the choline /N-acetyl aspartate ratio at MR spectroscopy
时间窗: Day 30
peak creatine at MR spectroscopy
时间窗: Day 30
Histological result at biopsy
时间窗: Day 31
histology as the gold standard for the diagnostic between radiation necrosis and relapse
次要结局
未报告次要终点