Spatial Analysis and Validation of Glioblastoma on 7 T MRI

August 16, 2018 updated by: Maastricht Radiation Oncology

Currently, patients with a glioblastoma multiforme (GBM) are treated with a combination of different therapeutic modalities including resection, concurrent chemo- and radiotherapy and adjuvant temozolomide. However, survival is still poor and most of these tumours recur within one to two years within the previously irradiated target volume.

The radiation target volume encompasses both the contrast-enhanced lesion on T1-weighted magnetic resonance imaging (MRI), plus a 1.5 - 2 cm isotropic margin in order to include microscopic speculated growth. These margins result in a high dose to surrounding healthy appearing brain tissue. Moreover, the short progression-free survival indicates a possible geographical miss. There is a clear need for novel imaging techniques in order to better determine the degree of tumour extent at the time of treatment and to minimize the dose to healthy brain tissue.

The development of Ultra-High Field (UHF) MRI at a magnetic field strength of 7 Tesla (T) provides an increased ability to detect, quantify and monitor tumour activity and determine post-treatment effects on the normal brain tissue as a result of a higher resolution, greater coverage and shorter scan times compared to 1.5 T and 3 T images. Up to now, only few investigators have examined the use of UHF MRI in patients with malignant brain tumours. These studies show its potential to assess tumour microvasculature and post-radiation effects such as microhaemorrhages.

This study analyzes the accuracy of the 7T MRI in identifying the gross tumour volume (GTV) in patients with an untreated GBM by comparing biopsy results to 7T images. These biopsies will be taken from suspected regions of GBM based on 7T MRI that do not appear as such on 3T MRI. We hypothesize that with the 7T MRI the GTV can be more accurately and extensively identified when compared to the 3T MRI.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ET
        • Maastricht Radiation Oncology (MAASTRO clinic)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Supratentorial tumour
  • Suspected GBM on diagnostic MRI
  • Eligible for biopsy
  • Minimum age 18 years or older
  • World Health Organization (WHO) Performance scale ≤2
  • American Society of Anaesthesiologist (ASA) class ≤ 3
  • Understanding of the Dutch language
  • Ability to comply to study procedure

Exclusion Criteria:

  • Recurrent tumour
  • Tumour location deemed unfit for extra biopsies
  • Prior radiotherapy to the skull
  • Prior chemotherapy
  • World Health Organization (WHO) Performance scale ≥ 3
  • American Society of Anaesthesiologist (ASA) class ≥ 3
  • Eligibility for immediate debulking
  • Contra-indications for gadolinium
  • Contra-indications for the MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biopsy
Subjects will receive a 7 T MRI and one additional biopsy to their standard diagnostic biopsies
Device: 7 T MRI
Overview Technical DetailsField strength: 7 Tesla Bore size: 60 cm System length: 317,5 cm RF power: 7,5 kW / 8x1 kW Gradient strength: SC 72 Gradients (max. 70 mT/m @ 200 T/m/s) Helium Consumption: Zero Helium boil-off technology
Other Names:
  • Siemens MAGNETOM 7
Procedure: Biopsy
During surgery patients will receive standard biopsies plus one study biopsy from a region of interest. The neuro-surgeon will determine the feasibility of the extra biopsy and the optimal biopsy tract. A screen capture from the neuronavigation system will be saved for each biopsy to relate the findings on 3T and 7T MRI to histopathology.
Other Names:
  • Brain biopsy
  • Tumor sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The co-localisation of the Gross Tumour Volume (GTV) on 7T MRI and 3T MRI
Time Frame: Six months after biopsy
The spatial overlap in GTV between 7T MRI and 3T MRI as well as inter- and intra-observer variability will be measured with the Dice Similarity Coefficient (DSC) and the mean of the slice-wise Hausdorff distances.
Six months after biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correspondence between glioblastoma cells found in the biopsies and region of interest (ROI) on the 7T MRI scan.
Time Frame: Within a month after biopsy
Pathological assessment of biopsy material compared with the ROI on 7T MRI
Within a month after biopsy
The co-localisation of the Clinical Target Volume (CTV) on 7T MRI and 3T MRI
Time Frame: Six months after the biopsy
The CTV includes the GTV plus a 1.5 cm isotropic margin and is adjusted to the anatomical borders and may be reduced in regions adjacent to sensitive structures. The spatial overlap in CTV between 7T and 3T MRI as well as inter- and intraobserver variability will be measured with the DSC and the mean of the slice wise Hausdorff distances.
Six months after the biopsy
The co-localisation of the organs at risk (OAR) on 7T - and 3T MRI
Time Frame: Six months after biopsy
The OARs (chiasm, optic nerves, pituitary gland, (subfields of) hippocampal formation and brainstem) will be delineated by 2 radiation-oncologists, a resident radiation-oncology, a radiation technologist and a neuroradiologist. The spatial overlap in OARs between 7T and 3T MRI as well as inter- and intraobserver variability measured by the DSC and the mean of the slice-wise Hausdorff distances.
Six months after biopsy
The correlation between the first tumour recurrence on 3T MRI follow-up images and ROI on the 7T MRI scan
Time Frame: approx. one month after tumour recurrence
The correlation between the first tumour recurrence on 3T MRI (perfusion) follow-up images and ROI on the pre-biopsy 7T MRI scan will be measured with the DSC and the mean of the slice-wise Hausdorff distances.
approx. one month after tumour recurrence
The quantification of tumour heterogeneity on 7T MRI and 3T MRI
Time Frame: Six months after biopsy
Quantification of tumour heterogeneity advanced Radiomics computer software that has been developed within Maastricht Radiation Oncology
Six months after biopsy
The visibility of white matter tracts on 7T MRI and 3T MRI
Time Frame: Six months after the biopsy
Visualization of white matter tracts will be done with the use of diffusion tensor imaging (DTI) on 7T MRI.
Six months after the biopsy
Tolerability and side effects 3T MRI and 7T MRI scan
Time Frame: After 3T MRI and 7T MRI
The tolerability and side effects will be evaluated with the comparison of two short questionnaires following the 3T and the 7T MRI scans
After 3T MRI and 7T MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Collaborators

The Limburg University Fund

Investigators

  • Principal Investigator: Philippe Lambin, prof, Maastricht Radiation Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2014

Primary Completion (ACTUAL)

February 5, 2018

Study Completion (ACTUAL)

February 5, 2018

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (ESTIMATE)

February 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1335-1812-intern-6485
  • 47894 (OTHER: CCMO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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