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

NCT01657734 | Completed

• 1 other identifier: S53303
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Gliomas

Keywords

therapy-induced inflammatory response with; magnetic resonance imaging

Study Arms (2)

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

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

Interventions

MR imaging OTHER

MR imaging

HGG2003; HGG2010

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with glioblastoma treated with dendritic cell therapy

You may qualify if:

• \*\*\*\* 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).

You may not qualify if:

• minor age

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

University Hospitals of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: August 6, 2012
• Study Start: September 1, 2011
• Primary Completion: February 18, 2016
• Study Completion: February 18, 2016
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (2)