|- candidate number||22535|
|- NTR Number||NTR5354|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-aug-2015|
|- Secondary IDs||2013/335 METC|
|- Public Title||Accuracy of glioma imaging |
|- Scientific Title||FRONTiers in advanced Imaging of unExplored glioma Regions|
|- hypothesis||1. Advanced neuroimaging, in combination with standard MRI, will have a superior diagnostic accuracy in comparison with standard MRI alone. |
2. Histological and molecular characteristics of glioma will correlate better with advanced imaging than standard imaging.
|- Healt Condition(s) or Problem(s) studied||Glioma|
|- Inclusion criteria||Patients of 18 years and older with a MRI interpretation by an expert neuroradiologist of a diffuse infiltrative glioma, and who have an indication, confirmed by the multidisciplinary neuro-oncology tumor-board, for resective surgery.|
|- Exclusion criteria||Patients who are pregnant or underwent previous brain surgery, cranial irradiation or chemotherapy. Patients with other brain pathology on MRI, such as stroke or multiple sclerosis. Patients with a tumor located infratentorially or in the spinal cord.
Patients who do not successfully undergo one PET scan in phase I and III or both PET scans in phase II.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-sep-2017|
|- Target number of participants||40|
|- Interventions||Observational study with PET and MRI previous to stereotactic biopsies in and around the tumor.|
|- Primary outcome||- Qualitative (high, normal or low signal) and quantitative parameters of MRI and PET for each biopsy site |
- Qualitative (central glioma, glioma infiltration, normal brain or uninformative) histopathological score of each biopsy site
|- Secondary outcome||- Gene expression of each biopsy site|
|- Timepoints||Phase I (n=8) 12 months|
Phase II (n=12) 12 months
Phase III (n=20) 12 months
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr.
de Witt Hamer
|- CONTACT for SCIENTIFIC QUERIES||Dr.
de Witt Hamer
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society, Cancer Centre Amsterdam|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||4-aug-2015 - 25-aug-2015|