Spatial Analysis and Validation of Glioblastoma on 7 T MRI

NCT02062372 | Terminated

• 2 other identifiers: 1335-1812-intern-648547894
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

7 T MRI; Radiotherapy; Glioblastoma; Biopsy

Outcome Measures

Primary Outcomes (1)

• The co-localisation of the Gross Tumour Volume (GTV) on 7T MRI and 3T MRI

  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 Outcomes (7)

• The correspondence between glioblastoma cells found in the biopsies and region of interest (ROI) on the 7T MRI scan.

  Within a month after biopsy

• The co-localisation of the Clinical Target Volume (CTV) on 7T MRI and 3T MRI

  Six months after the biopsy

• The co-localisation of the organs at risk (OAR) on 7T - and 3T MRI

  Six months after biopsy

• The correlation between the first tumour recurrence on 3T MRI follow-up images and ROI on the 7T MRI scan

  approx. one month after tumour recurrence

• The quantification of tumour heterogeneity on 7T MRI and 3T MRI

  Six months after biopsy

Study Arms (1)

Biopsy

EXPERIMENTAL

Subjects will receive a 7 T MRI and one additional biopsy to their standard diagnostic biopsies

Device: 7 T MRI; Procedure: Biopsy

Interventions

7 T MRI DEVICE

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

Also known as: Siemens MAGNETOM 7

Biopsy

Biopsy PROCEDURE

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.

Also known as: Brain biopsy, Tumor sampling

Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• The Limburg University Fund: collaborator

Study Sites (1)

Maastricht Radiation Oncology (MAASTRO clinic)

Maastricht, Limburg, 6229ET, Netherlands

Location

Related Publications (17)

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  BACKGROUND

• Kumar V, Gu Y, Basu S, Berglund A, Eschrich SA, Schabath MB, Forster K, Aerts HJ, Dekker A, Fenstermacher D, Goldgof DB, Hall LO, Lambin P, Balagurunathan Y, Gatenby RA, Gillies RJ. Radiomics: the process and the challenges. Magn Reson Imaging. 2012 Nov;30(9):1234-48. doi: 10.1016/j.mri.2012.06.010. Epub 2012 Aug 13.

  PMID: 22898692 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Glioblastoma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe Lambin, prof

  Maastricht Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: December 10, 2014
• Primary Completion: February 5, 2018
• Study Completion: February 5, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

NL (1)