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

Phase 1

• Conditions: Glioblastoma; MedDRA version: 19.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005838-19-FR
• Lead Sponsor: Hospics Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-21
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 204

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified