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Advanced MR Techniques in Detection of Tumor Infiltration and Grading in Gliomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225003
First Posted: October 20, 2010
Last Update Posted: September 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  Purpose

In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in optimal choice and planning of treatment.

Patients treated with gliomatous brain tumours are included voluntarily. They undergo one imaging session on a 3T MR scanner prior to treatment.

DKI data are quantitively analyzed in order to estimate specific parameters in normal appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed quantitatively and qualitatively with peak integration, ratio calculation and classification algorithms. Histological confirmation is obtained at subsequent surgery.

Information from this study can be of significant importance in avoiding brain biopsies. Furthermore, information on microscopic tumour spread can be used during neurosurgery or in radiotherapy planning. An important advantage of these advanced MR techniques is the non-invasivity and the lack of ionizing radiation, two important issues in this relatively young patient population.


Condition
Gliomas

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Diffusion Kurtosis Imaging en MR Spectroscopy in Grading and the Characterization of Tumour Infiltration in Gliomas

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Biospecimen Retention:   Samples Without DNA
standard neurosurgical procedure to obtain specimens; standard histopathological examination

Estimated Enrollment: 30
Study Start Date: July 2010
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients diagnosed with a gliomatuous brain tumor, prior to treatment
Criteria

Inclusion Criteria:

  • diagnosis of gliomatous brain tumour

Exclusion Criteria:

  • younger than 18 years of age
  • prior treatment
  • history of neurological or neurosurgical treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225003


Locations
Belgium
University Hospitals of Leuven
Leuven, Vlaams-Brabant, Belgium, 3001
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Stefan Sunaert, MD, PhD University Hospitals Leuven
Principal Investigator: Uwe Himmelreich, PhD Catholic University Leuven
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01225003     History of Changes
Other Study ID Numbers: S52302
First Submitted: October 19, 2010
First Posted: October 20, 2010
Last Update Posted: September 29, 2011
Last Verified: October 2010

Keywords provided by Universitaire Ziekenhuizen Leuven:
gliomas
magnetic resonance
diffusion kurtosis imaging
MR spectroscopy
grading

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue