No registrations found.
ID
Source
Brief title
Health condition
Glioblastoma; Glioblastoom
Brain tumour; Hersentumor
Magnetic Resonance Imaging
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is to establish the diagnostic accuracy of functional MRI techniques and MET-PET individually and combined in treatment evaluation of glioblastoma.
Secondary outcome
Not applicable
Background summary
Glioblastomas (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.
Study objective
Our 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.
Study design
In 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.
Intervention
This study aims to establish the diagnostic accuracy of functional MRI techniques and MET-PET individually and combined in treatment evaluation of glioblastoma.
A. Hoorn, van der
PO Box 30 001
Groningen 9700 RB
The Netherlands
+31503616161
a.van.der.hoorn@umcg.nl
A. Hoorn, van der
PO Box 30 001
Groningen 9700 RB
The Netherlands
+31503616161
a.van.der.hoorn@umcg.nl
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6536 |
| NTR-old | NTR6724 |
| CCMO | NL63082.042.17 |
| OMON | NL-OMON46687 |