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

Not Applicable

• Conditions: Primary Malignant Neoplasm of Nervous System; Metastasis; Glioma; Glioblastoma
• Interventions: Procedure: Control arm; Procedure: Interventional arm

• Registration Number: NCT01798771
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-25
• Last Update Submitted: 2013-02-25
• Study First Posted: 2013-02-26
• Last Update Posted: 2013-02-26
• Study Start: 2013-03
• Primary Completion: 2015-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Control arm	5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Interventional arm	Interventional arm	5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.

Primary Outcome Measures

Name	Time	Method
Extent of Resection	Early postoperative MRI within 72 hrs	The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.

Secondary Outcome Measures

Name	Time	Method
Volumetric extent of resection	Early postoperative MRI within 72hrs	Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.
PFS 6	6 months following surgery	Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection
PFS 12	12 months following surgery	Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection
Quality of life	6 months/12 months	Patient quality of life at 6 and 12 months following surgery is a secondary endpoint

Trial Locations

Locations (1)

Klinik für Neurochirurgie Johann Wolfgang Goethe University; 🇩🇪 Frankfurt am Main, Hessen, Germany