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MRI and MET-PET treatment evaluation in glioblastoma


- candidate number27958
- NTR NumberNTR6724
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-sep-2017
- Secondary IDsNL63082.042.17 Universitair Medisch Centrum Groningen
- Public TitleMRI and MET-PET treatment evaluation in glioblastoma
- Scientific TitlePROSPECTIVE LONGITUDINAL STUDY USING FUNCTIONAL MRI AND MET-PET IMAGING FOR TREATMENT EVALUATION IN GLIOBLASTOMA PATIENTS
- ACRONYMMRI and MET-PET treatment evaluation in glioblastoma
- hypothesisOur hypothesis is that a combination of functional MRI techniques and MET-PET shows a higher diagnostic accuracy than anatomical imaging or one functional MRI technique alone.
- Healt Condition(s) or Problem(s) studiedBrain tumor, Magnetic resonance imaging (MRI) , Glioblastoma
- Inclusion criteria- Adult patients with a new primary glioblastoma
- Scheduled to undergo standard treatment consisting of surgical resection followed by concomitant chemoradiation and adjuvant chemotherapy according to the Stupp protocol
- Informed consent must be obtained
- No exclusion criteria
- Exclusion criteria- Patients with a recurrent or secondary glioblastoma
- Patients with other intracranial tumours
- Patients with infratentorial glioblastoma
- Prior brain surgery or irradiation of the head
- Patients not scheduled for standard therapy (e.g. who will receive a biopsy without further resection)
- Minors (< 18 years of age)
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate31-dec-2020
- Target number of participants40
- InterventionsThis study aims to establish the diagnostic accuracy of functional MRI techniques and MET-PET individually and combined in treatment evaluation of glioblastoma.
- Primary outcomeThe primary outcome is to establish the diagnostic accuracy of functional MRI techniques and MET-PET individually and combined in treatment evaluation of glioblastoma.
- Secondary outcomeNot applicable
- TimepointsIn this prospective longitudinal cohort study 40 primary glioblastoma patients will undergo multimodal MRI and MET-PET within 72 hours after surgery to acquire a baseline scan. Follow-up scans will be acquired 10 weeks after concomitant chemoradiotherapy (CCRT) and then with 3 months intervals until anatomical follow-up MRI is suggestive of tumour recurrence. The final diagnosis will be made radioclinically or histologically.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. A. Hoorn, van der
- CONTACT for SCIENTIFIC QUERIESDr. A. Hoorn, van der
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryGlioblastomas (GBM) are the most malignant brain tumours with low survival rates. Treatment failure causes this tumour to inevitably recur, making close monitoring of GBM patients essential. The gold standard for follow-up is anatomical MR imaging based on contrast enhancement. However, this imaging method is hindered by pseudo-progression which can resemble true tumour progression, but is in fact due to treatment effects.
Functional imaging methods have been employed to overcome the limitations of anatomical MRI by measuring biological aspects of the tumour. Cellular density, tumour neovascularisation and tumour metabolites can be visualised by diffusion MRI, perfusion MRI and MR spectroscopy, respectively. Increased metabolism associated with tumour tissue is detectable with methionine PET (MET-PET). Although these functional imaging techniques individually showed promising results in differentiating pseudo-progression from true tumour progression, a large prospective study comparing all techniques directly in the same patients is lacking.

This study aims to establish the diagnostic accuracy of functional MRI techniques and MET-PET individually and combined in treatment evaluation of glioblastoma.
- Main changes (audit trail)
- RECORD28-sep-2017 - 28-okt-2017


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