Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.

Glioma Clinical Trial

Official title:

Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04461002
• Other study ID #: RadioGLioSign
• Status: Enrolling by invitation
• Start date: September 30, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).

Description:

A retrospective monocentre study of medical data (clinical, histological, molecular and imaging) contained in the medical records of patients operated on for Grade II or III incident glioma.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject 18 years of age or older, having been informed of the research
• Subject operated on with an incident glioma of grade II or III, histologically confirmed (WHO 2016 classification)
• Subject for which all preoperative imaging data is available (MRI, FDG and FDOPA PET-scan)
• Subject for which molecular data of the lesion are available

Exclusion Criteria:

• Subject having signified his opposition to the use of his medical data
• Subject under safeguard of justice, guardianship or trusteeship
• Subject with incomplete or missing part of the molecular and/or imaging data

Related Conditions & MeSH terms

• Glioma

Intervention

Other:
• Retrospective analysis
Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).

Locations

Country	Name	City	State
France	Hôpital Privé Clairval	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome	Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).	4 years
Secondary	Molecular profile	Evaluate the overall survival and progression-free survival of patients based on the molecular profile of gliomas.	4years
Secondary	Imaging data	To evaluate the overall survival and progression-free survival of patients based on imaging data (PET-scan and MRI) of gliomas.	4 years