MEDICO-ECONOMIC EVALUATION OF SURGERY GUIDED BY FLUORESCENCE FOR THE OPTIMIZATION OF THE RESECTION OF GLIOBLASTOMAS - THE RESECT STUDY - RESECT

Hospics Civils de Lyon0 个研究点目标入组 204 人开始时间: 2013年5月21日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•Pre inclusion criteria :
•-Age greater than 18 years.
•-Maggiore unprotected.
•-Patient-affiliated to a National Health Insurance.
•-Patient with intracerebral tumor, supra-tentorial hemispheric newly diagnosed and untreated previously, the MRI features suggestive of a glioblastoma.
•-Indication to surgical treatment by excision.
•-Against-No medical indication for surgery, ASA score less than 4.
•-Patient eligible for further treatment with radiotherapy and concurrent chemotherapy and adjuvant chemotherapy according to the scheme proposed by Stupp. (1) For patients older than 70 years, Stupp protocol, radiotherapy alone or chemotherapy will be administered according to the recommendations of each center after reviewing the file in RCP
•-Negative pregnancy test for women of childbearing age
•Inclusion criteria :
•-Tumor location accessible to excision as complete as possible validated by pre operative evaluation by a committee of surgery outside the center inclusion (majority opinion favorable surgical taken on 3 reviews)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Non inclusion criteria :
•-Contraindications to performing an MRI (pacemaker).
•-hypersensitivity to 5-ALA or porphyrins,
•-Hypersensitivity to parahydroxybenzoate of méthyle or propyl
•- Renal lithiasis oxalate-calcium
•- Glioblastoma-known and previously treated with surgery, radiotherapy and / or chemotherapy.
•-History of cancer.
•-Location tumor in the brainstem, the midline, basal ganglia or posterior cranial fossa.
•-Patient with cons-indication to the achievement of further processing. (1)
•-Patient with porphyria, renal failure (creatinine> 177 µmolL), liver (gamma glutamyl transpeptidase> 100 U / L, prothrombin time <60%, bilirubin> 51µmol / L).
•-Patient refused to sign a consent form.
•-Participation in the course of the patient to another trial.

发起方

Hospics Civils de Lyon