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| ID | Type | Description | Link |
|---|---|---|---|
| 206/12 | Other Identifier | Ethics Committee Johann Wolfgang Goethe University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Other | 5-ALA fluorescence guided surgery in patients with contrast enhancing tumors. |
|
| Interventional arm | Other | 5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional arm | Procedure | 5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS | The change of NIHSS (The NIH Stroke Scale) score is an other pre-specified outcome measure | 5 days following surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Senft, MD PhD | Contact | 069-6301 | 5939 | c.senft@med.uni-frankfurt.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian Senft, MD PhD | Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Neurochirurgie Johann Wolfgang Goethe University | Frankfurt am Main | Hesse | 60528 | Germany |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Control arm | Procedure | 5-ALA fluorescence guided surgery in patients with contrast enhancing tumors. |
|
|
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 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |