Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01657734
First received: September 7, 2011
Last updated: August 1, 2012
Last verified: May 2011

September 7, 2011
August 1, 2012
September 2011
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01657734 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Multimodal MR Imaging in Patients With Glioblastoma Treated With Dendritic Cell Therapy
Not Provided

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated with glioblastoma treated with dendritic cell therapy

Malignant Gliomas
Other: MR imaging
MR imaging
  • 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).

    Intervention: Other: 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).
    Intervention: Other: MR imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
Not Provided

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

Both
18 Years and older
No
Contact: Sofie Van Cauter, MD 16349071 ext +32 sofie.vancauter@uzleuven.be
Belgium
 
NCT01657734
S53303
Not Provided
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Not Provided
Universitaire Ziekenhuizen Leuven
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP