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Clinical Trials/NCT05806619
NCT05806619
Completed
Not Applicable

Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics

Regina Elena Cancer Institute2 sites in 1 country150 target enrollmentOctober 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glioma, Malignant
Sponsor
Regina Elena Cancer Institute
Enrollment
150
Locations
2
Primary Endpoint
Correlation between MR and molecular data
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Main limitations in Glioma studies are due to the wide heterogeneity and genetic instability of the tumor and to the fact that the molecular informations are static, i.e. obtained on the tumor at its onset. Instead, spontaneous or therapy-induced variations are difficult to evaluate and they would need further sampling of the tumor throughout the clinical history. Currently these data are more and more routinely used not only for diagnostics but also in the clinical management of the patient.

Furthermore, microenvironment study is becoming increasingly important. It is also important correlate morpho-functional pathway and brain Magnetic Resonance.

Therefore, the main goal of the study is to correlate the data obtained with morphological (site, signal intensity, margins, behavior after contrast medium infusion, mismatch between T2 and FLAIR sequences) and non-morphological MR imaging through a radiomic approach and Diffusion and Perfusion study, with molecular data relating to the IDH mutation, MGMT gene promoter methylation, 1p/19q co-deletion and EGFRvIII expression.

Furthermore, it is proposed to carry out a correlation between the radiological data and the mutations found in the NGS panel.

Registry
clinicaltrials.gov
Start Date
October 22, 2019
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • glioma diagnosis
  • have performed morphological brain MRI or not with contrast medium before surgery
  • informed consent form

Exclusion Criteria

  • Patients without Magnetic Resonance were excluded

Outcomes

Primary Outcomes

Correlation between MR and molecular data

Time Frame: 24 months

Demonstrate the existence of a correlation between the non-morphological brain Magnetic Resonance (MR) data obtained with diffusion and perfusion techniques and molecular data, in particular with MGMT gene methylation.

Study Sites (2)

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