Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| IKP | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Active Comparator | 0,2 mg/Kg |
|
| Dose level 2 | Active Comparator | 2,0 mg/Kg |
|
| Dose level 3 | Active Comparator | 20 mg/Kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gliolan | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma). | After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically. | Within 3 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Porphyria, hypersensitivity to porphyrins
Renal insufficiency:
Hepatic insufficiency:
Other known malignancy (except basaliomas)
Women:
Men:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |