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

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Malignant Neoplasm of Nervous System, Glioma, Glioblastoma, Metastasis

Intervention / Treatment
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* Procedure: Interventional arm
* Procedure: Control arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm<br>5-ALA fluorescence guided surgery in patients with contrast enhancing tumors. | Procedure: Control arm<br>* 5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.<br>* Other names: 5-Aminolevulinic acid hydrochloride;|
| Other: Interventional arm<br>5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors. | Procedure: Interventional arm<br>* 5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.<br>* Other names: 5-Aminolevulinic acid hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Resection | The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI. | Early postoperative MRI within 72 hrs | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary brain tumor, malignant glioma, intraoperative MRI, 5-ALA