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

NCT01811121 | Completed Phase 3 DMC

• 1 other identifier: 2011-697
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is based mainly on surgical excision as complete as possible followed by an additional radiochemotherapy. The prognosis depends mainly on the quality of resection when it is macroscopically complete. Different techniques to support the surgical resection have been developed over the past 20 years. The reference technique is currently the intraoperative neuronavigation for guiding excision by matching the intraoperative tumor boundaries with those of the preoperative MRI. Its main drawback is the loss of precision during the resection related to changes in anatomical limits of the tumor. The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique to support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by the patient before surgery is captured specifically by the tumor cells and transformed into a fluorochrome revealed intraoperatively by a light source length adapted wave with a set of lenses included in the microscope. Resection is thus guided by this fluorescence whose disappearance translates complete tumor resection. Its interest is twofold:

• Increase the percentage of complete tumor resection.
• Improve disease-free survival and overall survival. The objective of the study is to compare the FGS to the intraoperative neuronavigation for the resection of glioblastoma, on a medical and economical level through a randomized, prospective, multicenter trial. The annual number of patients likely to benefit of this technique in France is estimated at 2200 new cases.

Conditions

Glioblastoma

Keywords

Glioblastoma; 5ALA; fluorescence; resection

Outcome Measures

Primary Outcomes (1)

• Comparison of complete tumor resection between the 2 arms

  Evidenced of complete resection (absence of residual tumor on early postoperative MRI (within 48 hours)) will be assessed by a central independent committee with qualitative analysis of contrast enhancement replay on a console for diagnostic use.

  48 hours

Secondary Outcomes (1)

• Comparison of complete tumor resection between the 2 arms

  less than 48 hours after surgery

Other Outcomes (9)

• Diagnostic value of the two intraoperative techniques

  60 months

• Quantification of residual tumor (contrast enhancement) on MRI post-opératre early (before 48 hours)

  before 48 hours

• Progression Free survival rate at 6 months

  6 months

Study Arms (2)

5-aminolévulinique acid (5-ALA)

EXPERIMENTAL

5-aminolévulinique acid :microsurgical resection guided by fluorescence (CGF) in addition to the usual techniques of neuronavigation, after oral administration of 20mg/kg of 5-ALA 3-5 hours prior to surgical incision

Drug: 5-aminolévulinique acid (5-ALA)

Placebo

PLACEBO COMPARATOR

Laroscorbine :microsurgical excision guided solely by neuronavigation, after oral administration of a placebo 3 to 5 hours before the surgical incision

Drug: Placebo

Interventions

5-aminolévulinique acid (5-ALA) DRUG

oral administration of 20mg/kg of 5-ALA 3-5 hours before the surgical incision

Also known as: Bras A

5-aminolévulinique acid (5-ALA)

Placebo DRUG

Oral administration of 1g of ascorbic acid LAROSCORBINE in 50ml of water 3 hours before surgery

Also known as: Bras B

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years with no upper age limit
• Competent adult patient.
• Patient affiliated to the National Health Insurance.
• Patient with an intra-cerebral supra-tentorial hemispheric, newly diagnosed and previously untreated, which MRI characteristics are suggestive of a glioblastoma.
• Indication for surgical treatment by excision.
• Brain tumor location distant from critical functional areas allowing a wide resection of contrast enhancement on imaging, the a priori character completely resectable has been validated by an evaluation committee composed of three surgeons
• No-cons contain medical surgery, ASA score below 4.
• Patient eligible for further treatment by radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the so called Stupp scheme (standard protocol of adjuvant chemoradiotherapy)
• Negative pregnancy test for women of childbearing age.

You may not qualify if:

• Contraindications to performing an MRI (pacemaker).
• Glioblastoma known and previously treated with surgery, radiotherapy and / or chemotherapy.
• History of cancer.
• Anatomical Location of the tumor-cons indicating a wide excision, neurosurgeon at the discretion of medical officer participating center.
• Location tumor in the brain stem, the middle line, the basal ganglia and the posterior cranial fossa.
• Patient with cons-indication to the achievement of further treatment with radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the scheme proposed by Stupp. (1)
• Patients with porphyria, renal insufficiency (creatinine\> 177 μmolL), liver insufficency(gamma glutamyl transpeptidase\> 100 U / L, prothrombin time \<60%, bilirubin\> 51μmol / L).
• Patient refused to sign an informed consent form.
• Ongoing participation of the patient to another clinical trial.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Guyotat

Lyon, France

Location

Related Publications (2)

• Rioufol G, Derimay F, Roubille F, Perret T, Motreff P, Angoulvant D, Cottin Y, Meunier L, Cetran L, Cayla G, Harbaoui B, Wiedemann JY, Van Belle E, Pouillot C, Noirclerc N, Morelle JF, Soto FX, Caussin C, Bertrand B, Lefevre T, Dupouy P, Lesault PF, Albert F, Barthelemy O, Koning R, Leborgne L, Barnay P, Chapon P, Armero S, Lafont A, Piot C, Amaz C, Vaz B, Benyahya L, Varillon Y, Ovize M, Mewton N, Finet G; FUTURE Trial Investigators. Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. J Am Coll Cardiol. 2021 Nov 9;78(19):1875-1885. doi: 10.1016/j.jacc.2021.08.061.

  PMID: 34736563 RESULT

• Picart T, Pallud J, Berthiller J, Dumot C, Berhouma M, Ducray F, Armoiry X, Margier J, Guerre P, Varlet P, Meyronet D, Metellus P, Guyotat J; Members of RESECT study group:. Use of 5-ALA fluorescence-guided surgery versus white-light conventional microsurgery for the resection of newly diagnosed glioblastomas (RESECT study): a French multicenter randomized phase III study. J Neurosurg. 2023 Oct 13;140(4):987-1000. doi: 10.3171/2023.7.JNS231170. Print 2024 Apr 1.

  PMID: 37856381 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jacques GUYOTAT, MD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: March 14, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2019
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

FR (1)