Multimodal MR Imaging in Patients With Glioblastoma Treated With Dendritic Cell Therapy

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01657734
Collaborator
(none)
30
2
15

Study Details

Study Description

Brief Summary

Malignant gliomas are aggressive tumours with poor prognosis despite the current multimodal treatment. Hence, there is a clear need for new, effective therapies, among which immune therapy has emerged as a promising treatment option.

When interpreting follow-up magnetic resonance (MR) examinations, the radiologist is often confronted with images that are difficult to interpret with the conventional anatomical imaging techniques. The difference between tumour relapse and therapy-mediated changes is not always distinctive.

In this project, the investigators attempt to characterize the inflammatory response with parameters from advanced MRI techniques like MR spectroscopy, MR perfusion imaging and MR-diffusion imaging. These techniques allow characterization of cellular properties like metabolism and tissue structure respectively. Doing so, the investigators will monitor disease evolution in order to timely detect treatment failure, thereby allowing appropriate switch in patient management.

Condition or Disease Intervention/Treatment Phase
  • Other: MR imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Study Start Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
HGG2003

**** patients enrolled in the HGG 2003 HGG-IMMUNO 2003 trial Patients, older than 3 and younger than 60 years with relapse of high-grade glioma (anaplastic astrocytoma WHO grade III or glioblastoma multiforme WHO grade IV), histologically diagnosed in the first stage of the disease as well as after relapse or relapse of glioma which was grade II in the First phase but grade III or IV upon relapse are treated with dendritic cell therapy (immunotherapy) as single treatment approach (No radiotherapy and/or chemotherapy).

Other: MR imaging
MR imaging

HGG2010

**** patients enrolled in the HGG 2010 HGG-IMMUNO 2010 trial prospective double blind placebo controlled randomised clinical trial HGG-2010 for patients with newly diagnosed glioblastoma in which immunotherapy is integrated in the current standard of care (concommitant radiochemotherapy).

Other: MR imaging
MR imaging

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    **** patients enrolled in the HGG 2003 HGG-IMMUNO 2003 trial

    Patients, older than 3 and younger than 60 years with relapse of high-grade glioma (anaplastic astrocytoma WHO grade III or glioblastoma multiforme WHO grade IV), histologically diagnosed in the first stage of the disease as well as after relapse or relapse of glioma which was grade II in the First phase but grade III or IV upon relapse are treated with dendritic cell therapy (immunotherapy) as single treatment approach (No radiotherapy and/or chemotherapy).

    **** patients enrolled in the HGG 2010 HGG-IMMUNO 2010 trial

    • prospective double blind placebo controlled randomised clinical trial HGG-2010 for patients with newly diagnosed glioblastoma in which immunotherapy is integrated in the current standard of care (concommitant radiochemotherapy).
    Exclusion Criteria:

    minor age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Leuven Leuven Vlaams-Brabant Belgium 3000
    2 University Hospitals of Leuven Leuven Vlaams-Brabant Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01657734
    Other Study ID Numbers:
    • S53303
    First Posted:
    Aug 6, 2012
    Last Update Posted:
    Aug 6, 2012
    Last Verified:
    May 1, 2011
    Keywords provided by Universitaire Ziekenhuizen Leuven
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 6, 2012