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Accuracy of glioma imaging


- candidate number22535
- NTR NumberNTR5354
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2015
- Secondary IDs2013/335 METC
- Public TitleAccuracy of glioma imaging
- Scientific TitleFRONTiers in advanced Imaging of unExplored glioma Regions
- ACRONYMFRONTIER
- hypothesis1. 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) studiedGlioma
- Inclusion criteriaPatients 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 criteriaPatients 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.

Withdrawal criteria Patients who do not successfully undergo one PET scan in phase I and III or both PET scans in phase II.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate1-sep-2017
- Target number of participants40
- InterventionsObservational 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
- TimepointsPhase I (n=8) 12 months
Phase II (n=12) 12 months
Phase III (n=20) 12 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P.C. de Witt Hamer
- CONTACT for SCIENTIFIC QUERIESDr. P.C. de Witt Hamer
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society, Cancer Centre Amsterdam
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-aug-2015 - 25-aug-2015


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