Clinical trial NCT00780819: Borderzone Sampling
Official title: Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Grade Glioma
Glioblastoma
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: On regular (diagnostic) MRI images brain tumors can show "contrast enhancement": uptake of an intravenously administered contrast agent can cause an enhancement pattern that is seen as a white area on a frequently used MRI protocol ("T1 weighted imaging"). High grade gliomas are a common brain tumor that share this enhancement pattern. The goal of surgery is to resect this contrast enhancing part without causing additional neurological damage. Intraoperative MRI (iMRI) is a helpful tool in achieving this goal, because it can provide updated images during resection and correct for deformations that occur in the brain during surgery. These deformations make preoperative images that are used for standard neuronavigation systems less reliable. However, due to manipulations during surgery, the contrast uptake during surgery may differ from contrast uptake in diagnostic MRI. This study aims to relate contrast enhancement on iMRI and tumor characteristics on tissue samples from the tumor. When the neurosurgeon considers the resection of the high grade glioma to be complete, an iMRI scan will be made, and tissue sampling will be performed on the borderzones of the tumor or tumor resection cavity respectively. This will provide insight in the relation between contrast enhancement on iMRI and the presence of tumor tissue. Such knowledge is important to improve effectiveness and safety of iMRI guided brain tumor resection.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: after surgery, and after 1 year for additional immunochemistry
Secondary outcomes:
measure: The relation between possible contrast enhancement and contrast enhancing tissue volume on the last intraoperative MRI scan and the early diagnostic MRI scan
timeFrame: within 72 hours after surgery
measure: Postoperative clinical condition (WHO Performance Scale)
timeFrame: 1 week after surgery
measure: Survival (Kaplan Meier)
timeFrame: after 4 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Pieter L Kubben, MD
role: PRINCIPAL_INVESTIGATOR
References: