This study aims to establish the diagnostic accuracy of functional MRI techniques and MET-PET individually and combined in treatment evaluation of glioblastoma.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy for differentiating between tumour recurrence and
treatment effects will be compared for each imaging sequence independently and
for the combinations. Longitudinal quantitative data will be extracted for each
imaging technique.
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.
Study objective
This study aims to establish the diagnostic accuracy of functional MRI
techniques and MET-PET individually and combined in treatment evaluation of
glioblastoma.
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.
Study burden and risks
MRI and PET scanning is a routine and very safe procedure in clinical practice.
Participation in this study will result in a prolongation of 10 minutes in MRI
scanning. The extra PET scan has an additional scanning time of 25 minutes. As
all glioblastoma patients will receive radiotherapy to the brain, irradiation
from the PET is negligible.
Hanzeplein 1 Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1 Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
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 a other intracranial tumour
- 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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63082.042.17 |