NCT01225003

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
Last Updated

September 29, 2011

Status Verified

October 1, 2010

First QC Date

October 19, 2010

Last Update Submit

September 28, 2011

Conditions

Keywords

gliomasmagnetic resonancediffusion kurtosis imagingMR spectroscopygrading

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients diagnosed with a gliomatuous brain tumor, prior to treatment

You may qualify if:

  • diagnosis of gliomatous brain tumour

You may not qualify if:

  • younger than 18 years of age
  • prior treatment
  • history of neurological or neurosurgical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leuven

Leuven, Vlaams-Brabant, 3001, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

standard neurosurgical procedure to obtain specimens; standard histopathological examination

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Stefan Sunaert, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR
  • Uwe Himmelreich, PhD

    Catholic University Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 20, 2010

Study Start

July 1, 2010

Last Updated

September 29, 2011

Record last verified: 2010-10

Locations