different types of brain tumors
Conditions
Brief summary
Primary endpoint is the incidence of adverse events of CTCAE Version 4.0 grades III, IV or V (excluding chemotherapy-associated toxicities) during and after 5-ALA fluorescence-guided resections in children and adolescents with unifocal, , contrast-enhancing intra-axial brain tumors.
Detailed description
The true positive rate of 5-ALA-induced fluorescence for predicting bulk tumor tissue, or tumor at the border area or infiltrating tumor will be determined from histopathology of fluorescing tissue biopsies. Only tissue, which is destined for removal under white light conditions due to its appearance and resectability, is to be assessed. The location of residual tissue which is left unresected and which shows fluorescence will be documented by the neurosurgeon., For the determination of the degree of resection, for every patient in whom a complete resection of enhancing tumor is expected a priori, it will be assessed whether there is residual contrast-enhancement visible on early post-operative MRI. The relationship between residual fluorescence and possible residual enhancing tumor will be described qualitatively., If possible and if consent is given, blood samples will be collected 3 times within 12h after administration of 5-ALA for determination of PPIX in plasma to elucidate 5-ALA metabolism in children and adolescents.
Interventions
Sponsors
Universitaet Muenster
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the incidence of adverse events of CTCAE Version 4.0 grades III, IV or V (excluding chemotherapy-associated toxicities) during and after 5-ALA fluorescence-guided resections in children and adolescents with unifocal, , contrast-enhancing intra-axial brain tumors. | — |
Secondary
| Measure | Time frame |
|---|---|
| The true positive rate of 5-ALA-induced fluorescence for predicting bulk tumor tissue, or tumor at the border area or infiltrating tumor will be determined from histopathology of fluorescing tissue biopsies. Only tissue, which is destined for removal under white light conditions due to its appearance and resectability, is to be assessed. The location of residual tissue which is left unresected and which shows fluorescence will be documented by the neurosurgeon., For the determination of the degree of resection, for every patient in whom a complete resection of enhancing tumor is expected a priori, it will be assessed whether there is residual contrast-enhancement visible on early post-operative MRI. The relationship between residual fluorescence and possible residual enhancing tumor will be described qualitatively., If possible and if consent is given, blood samples will be collected 3 times within 12h after administration of 5-ALA for determination of PPIX in plasma to elucidate 5-ALA | — |
Countries
Germany, Netherlands
Outcome results
None listed