Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging

Not Applicable

Recruiting

• Conditions: High Grade Serous Ovarian Cancer
• Interventions: Biological: Blood sample and tissue sample

• Registration Number: NCT06084195
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance

Detailed Description

After being informed about the study and potential risks, all patient giving wirtting informed consent.

During surgery, tissue and blood samples will be conserved for the study. In this study will be compared images obtained in vivo before surgical management, ex vivo images obtained on excised tissues during surgery, histological data obtained during surgery.

Study Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Study Start: 2023-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Patient aged >18
• Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment
• Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,
• Patient who has given informed, written and express consent,
• Patient affiliated with a French health insurance scheme.

Exclusion Criteria

• Early-stage disease (FIGO <IIIB) or presence of extraperitoneal metastases,
• Patient who will not have surgery
• Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
• Patient under guardianship, curatorship or safeguarding of justice,
• Pregnant and/or nursing patient,
• Patient with a history of other cancers within 5 years/10 years prior to inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Blood sample and tissue sample	single arm

Primary Outcome Measures

Name	Time	Method
the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cancer.	one shoot at the surgery	The diagnostic performance of the radiomic and multiomic algorithm for the characterization of heterogeneity in the CSOHG.

Secondary Outcome Measures

Name	Time	Method
the imaging phenotype of tumor heterogeneity with a multi-scale radiomic approach by obtaining the image mirror tumor at the in vivo scale	one shoot at the surgery	Correlation between radiomic maps and pathogenic maps of heterogeneity,
tumor heterogeneity based on phenotypic imaging supported by AI reflects and can predict sub-histologyunderlying by tumor stroma proportion and tumor density infiltrating lymphocytes and genomics through HRD	one shoot at the surgery	Correlation between radiomic algorithms and i/underlying histology and ii/ genomics
the heterogeneity of the tumor biology of CSOHG through non-invasive habitat imaging combined with an integrated Multi-O-Mics approach.	one shoot at the surgery	Correlation between radiomic maps and tumor biology (CYTOF, proteomics and transcriptomics),
To Correlate MRI results with hematological molecular biology results.	one shoot at the surgery	Correlation between radiomic algorithms for tumor detection and cDNA determination.

Trial Locations

Locations (1)

NOUGARET Stephanie; 🇫🇷 Montpellier, France