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

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: Glioblastoma; Glioma; Metastasis; Primary Malignant Neoplasm of Nervous System

Treatments: Procedure: Interventional arm; Procedure: Control arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01798771

JohannWGUH_IMAGER

206/12 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Control arm

Other group

Description:

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

Treatment:

Procedure: Control arm

Interventional arm

Other group

Description:

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

Treatment:

Procedure: Interventional arm