Glioblastoma, Glioma, Metastasis, Primary Malignant Neoplasm of Nervous System
Conditions
Keywords
primary brain tumor, malignant glioma, intraoperative MRI, 5-ALA
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.
Interventions
PROCEDUREInterventional arm
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
PROCEDUREControl arm
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| NIHSS | 5 days following surgery | The change of NIHSS (The NIH Stroke Scale) score is an other pre-specified outcome measure |
Countries
Germany
Contacts
Primary ContactChristian Senft, MD PhD
Outcome results
None listed