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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
Sponsor:
Collaborator:
Ecole Polytechnique Fédérale de Lausanne
Information provided by (Responsible Party):
Andreas Hottinger, Centre Hospitalier Universitaire Vaudois

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. GBM metabolites using high resolution spectroscopy [ Time Frame: 2 years ]
    High resolution spectroscopy metabolite analysis of GBM

  2. Next generation sequencing of GBM tumor tissue [ Time Frame: 2 years ]
    Molecular comparison of primary GBM tumor and paired orthotropic xenograft



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High level of suspicion of glioblastoma
  • Planned neurosurgical resection
  • Adequate bone marrow function
  • Adequate liver and kidney function

Exclusion Criteria:

  • inability to undergo MRI
  • inability to undergo neurosurgical resection

Information from the National Library of Medicine

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


Contacts
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Contact: Andreas F Hottinger, MD-PhD +41 21 314 0168 andreas.hottinger@chuv.ch
Contact: Laurence Benoit +41 21 314 0168 laurence.benoit@chuv.ch

Locations
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Switzerland
CHUV, University Hospital Lausanne Recruiting
Lausanne, VD, Switzerland, 1066
Contact: Andreas F Hottinger, MD, PhD    +41 21 314 0168    andreas.hottinger@chuv.ch   
Contact: Laurence Benoit    +41 21 314 0168    laurence.benoit@chuv.ch   
Sponsors and Collaborators
Andreas Hottinger
Ecole Polytechnique Fédérale de Lausanne
Investigators
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Study Chair: Andreas F Hottinger, MD-PhD CHUV Lausanne University Hospital

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Responsible Party: Andreas Hottinger, PI- Sponsor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02904525     History of Changes
Other Study ID Numbers: 268/14
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Andreas Hottinger, Centre Hospitalier Universitaire Vaudois:
newly diagnosed
MRI

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue