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
  Purpose

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 Intervention
Malignant Gliomas
Other: MR imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Estimated Enrollment: 30
Study Start Date: September 2011
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated with glioblastoma treated with dendritic cell therapy

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657734

Contacts
Contact: Sofie Van Cauter, MD 16349071 ext +32 sofie.vancauter@uzleuven.be

Locations
Belgium
University Hospitals of Leuven Active, not recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
University Hospitals Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Sofie Van Cauter, MD    16349071 ext +32    sofie.vancauter@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01657734     History of Changes
Other Study ID Numbers: S53303
Study First Received: September 7, 2011
Last Updated: August 1, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
therapy-induced inflammatory response with
magnetic resonance imaging

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

ClinicalTrials.gov processed this record on July 22, 2014