Glioblastoma: Validation and Comparison Between Primary Tumor and Its Murine Model (XENOGBM)
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|ClinicalTrials.gov Identifier: NCT02904525|
Recruitment Status : Unknown
Verified September 2016 by Andreas Hottinger, Centre Hospitalier Universitaire Vaudois.
Recruitment status was: Recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Despite maximal safe surgery followed by combined chemo-radiation therapy, the outcome of patients suffering from glioblastoma (GBM) remains extremely poor with a median survival of 15 months. Hence, new avenues have to be taken to improve outcome in this devastating disease. Given their intracerebral localization and their highly invasive features, GBM pose some specific challenges for the development of adequate tumor models. Orthotopic xenograft models directly derived from the tumor of a patient might represent an attractive perspective to develop patient-specific targeted therapies. This approach remains however to be validated for GBM as it offers specific challenges, including the demonstration that the properties of xenograft models validly represent treatment relevant features of the respective human tumors.
In this innovative project the investigators aim to compare and validate an approach of paired human GBM and respective derived orthotopic xenografts in the mouse brain on the levels of radiological behavior and metabolism of the tumors, as determined by high resolution MRI of the patients (7T MRI) and the respective orthotopic mouse xenografts (14.1T MRI), as well as on the level of the transcriptome, genome, and methylome of the original GBM tissue and respective derived xenografts/glioma sphere lines. The data will be integrated in multidimensional analyses and interrogated for similarities and associations with molecular GBM subtype.
This pilot project will provide the basis for the crucial next steps, which will include drug intervention studies. New promising drugs, tested pre-clinically in the mouse orthotopic xenograft models established here using the radiologic/metabolic/molecular procedures described for this project, will be taken into patients in phase 0 studies. GBM patients will receive radiologic/metabolic follow-up using high resolution MRI under drug treatment, followed by resection of the tumor and subsequent acquisition of molecular data.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Device: 7 Tesla MRI, no contrast agent||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Towards Patient-specific Treatments in Glioblastoma: Comparison and Validation of High-resolution Imaging and Molecular Profiles of Human Glioblastoma and Respective Paired Orthotopic Xenografts in the Mouse|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: 7T MRI + high resolution spectroscopy
Next to routine imaging, patients undergo an additional 7 tesla MRI for high resolution spectroscopy
Device: 7 Tesla MRI, no contrast agent
Patients with newly diagnosed glioblastoma undergo a 7Tesla MRI
- GBM metabolites using high resolution spectroscopy [ Time Frame: 2 years ]High resolution spectroscopy metabolite analysis of GBM
- Next generation sequencing of GBM tumor tissue [ Time Frame: 2 years ]Molecular comparison of primary GBM tumor and paired orthotropic xenograft
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904525
|Contact: Andreas F Hottinger, MD-PhD||+41 21 314 email@example.com|
|Contact: Laurence Benoit||+41 21 314 firstname.lastname@example.org|
|CHUV, University Hospital Lausanne||Recruiting|
|Lausanne, VD, Switzerland, 1066|
|Contact: Andreas F Hottinger, MD, PhD +41 21 314 0168 email@example.com|
|Contact: Laurence Benoit +41 21 314 0168 firstname.lastname@example.org|
|Study Chair:||Andreas F Hottinger, MD-PhD||CHUV Lausanne University Hospital|