This study wants to evaluate on intraoperative MRI whether contrast enhancement at the borders of the resection cavity correlates with tumor tissue, and whether no contrast enhancement correlates with the absence of tumor tissue. To differentiate…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relation between the shape and size of contrast enhancement on
intraoperative MRI at the resection cavity border, and the presence of residual
tumor tissue.
Secondary outcome
* The relation between possible contrast enhancement and contrast enhancing
tissue volume on the last intraoperative MRI scan and the early diagnostic MRI
scan (within 72 hours after surgery).
* Postoperative clinical condition (WHO Performance Scale).
* Survival (Kaplan Meier)
Background summary
The gold standard in brain tumor resection is to resect the contrast enhancing
part as visible on pre- and postoperative MRI. During surgery several changes
occur that may influence the contrast uptake by tumor tissue. The growing
availability of intraoperative MRI requires a systematic evaluation to decide
whether the gold standard can be applied on intraoperative MRI as well.
Study objective
This study wants to evaluate on intraoperative MRI whether contrast enhancement
at the borders of the resection cavity correlates with tumor tissue, and
whether no contrast enhancement correlates with the absence of tumor tissue. To
differentiate there will be particular attention for the shape and size of
contrast enhancement. This will be compared with a quantitative analysis of the
biopsies (cellular density, proliferation and vascularisation).
Study design
Included patients will be operated by a neurosurgeon who has experience with
the use of intraoperative MRI (H van Santbrink, dr M ter Laak-Poort of dr O
Schijns). Before and after surgery a WHO Performance Scale will be scored.
During surgery, separate biopsies will be taken from the border of the
resection cavity. These biopsies are collected with the aid of navigation, to
correlate the shape and size of the possible enhancement with the histological
findings. The neuropathologist will not only present a histological diagnosis,
but he will also provide a quantitative analysis regarding cell density,
proliferation and vascularisation of the tissue. These results will be compared
to the intraoperative MRI scan to answer the study question.
Intervention
Intraoperative MRI guided resection of a brain tumor with navigation guided
biopsies from the borders of the resection cavity after acquiring
intraoperative MRI images.
Study burden and risks
For patients there will be no additional burden by participating in this study,
except that the surgery will take 90-120 minute longer. Of course brain surgery
has its risks, but the risk profile is not likely to be increased by this
study. The study protocol contains supportive literature references on this
topic.
Postbus 5800
6202 AZ Maastricht
NL
Postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
- supratentorial brain tumor, on contrast enhanced MRI suspect for a high grade glioma
- indication for resection of the tumor
- age >= 18 years
- WHO Performance Scale <= 2
- ASA class <= 3
- good knowledge of the Dutch language
- informed consent
Exclusion criteria
- recurrent tumor
- multiple tumor localizations
- prior radiotherapy on the skull
- prior chemotherapy
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 | NL17679.068.07 |