To determine the diagnostic accuracy of VAI for the differentiation of treatment effects from tumour progression.
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
Primary endpoints are true positive, false positive, true negative, and false
negative values of VAI MRI. The reference will be definitive diagnosis
according to standard radiological follow-up.
Secondary outcome
Not applicable.
Background summary
The current conventional MRI techniques are not capable of reliably evaluating
treatment response in glioblastomas. Progression of the tumour can not always
be distinguished from treatment effects. More advanced MRI techniques that
focus on the biological properties of the tumour are promising. Recently, a
novel perfusion-MRI technique became available, vessel architectural imaging
(VAI). VAI can visualise tumor neovascularisation. Glioblastomas demonstrate
increased neovascularisation with subsequent hyperperfusion. This angiogenesis
is seen as a key in the development of tumour progression. With VAI it is
potentially possible to more reliably differentiate between tumour progression
and treatment effects. The diagnostic accuracy of VAI for the treatment
response evaluation in glioblastoma has never been investigated.
Study objective
To determine the diagnostic accuracy of VAI for the differentiation of
treatment effects from tumour progression.
Study design
A prospective pilot study for the diagnostic accuracy of VAI for the treatment
response evaluation of patients with a glioblastoma.
Study burden and risks
Participants will not have any advantages from participation in the research.
Participants will undergo one extra MRI scan (VAI) along their normal follow-up
MRI schedule. This research scan is comparable with the standard clinical MRI
scans. After intravenous administration of a contrast agent (gadolinium) scan
time will be approximately 30 minutes.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
- Histological confirmed glioblastoma after standard treatment
- New contrast enhancing lesion on follow-up MRI
- Written informed consent
Exclusion criteria
- Minors (<18 years)
- Subtotal resection of the tumour resulting in residual enhancement on post-operative MRI
- History of previous new enhancing lesion on follow-up MRI
- Treatment different than standard treatment
- Contraindication for MRI (ferromagnetic material in body, pregnancy, claustrophobia)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65208.042.18 |