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Borderzone Sampling

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00780819
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Maastricht University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pieter L Kubben, MD
Principal Investigator Affiliation Maastricht University Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

High Grade Glioma, Glioblastoma
Arms & Interventions

Arms

Experimental: PoleStar N20 intraoperative MRI

PoleStar N20 intraoperative MRI

Interventions

Device: - PoleStar N20 intraoperative MRI

low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

Status

Address

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ