Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery

Johann Wolfgang Goethe University Hospital108 enrolled

Overview

The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

108

Conditions

Primary Malignant Neoplasm of Nervous System Glioma Glioblastoma Metastasis

Interventions

Interventional armPROCEDURE

5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.

Control armPROCEDURE

5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patient (\> 18 years) able to give informed consent * primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma * tumor must be deemed completely resectable by neurosurgeon * diagnostic MRI Exclusion Criteria: * patient unable or unwilling to give informed consent * infratentorial tumor location * tumor location in or near eloquent areas * multifocal tumor * existance of contraindications to undergo MRI examination * previous surgical treatment for an intraaxial brain tumor

Locations (1)

Klinik für Neurochirurgie Johann Wolfgang Goethe University

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

Extent of Resection

The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.

Time frame: Early postoperative MRI within 72 hrs

Secondary Outcomes

Volumetric extent of resection

Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.

Time frame: Early postoperative MRI within 72hrs

PFS 6

Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection

Time frame: 6 months following surgery

PFS 12

Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection

Time frame: 12 months following surgery

Quality of life

Patient quality of life at 6 and 12 months following surgery is a secondary endpoint

Time frame: 6 months/12 months

Central Contacts

Christian Senft, MD PhD

CONTACT

069-6301 c.senft@med.uni-frankfurt.de

Data from ClinicalTrials.gov

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