Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging (MR-O-MICS)

February 11, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
single arm
Biological: Blood sample and tissue sample

During the surgery :

  • Tissus sample : primary tumor and metastasis
  • blood sample : 3 EDTA tubes
  • ex vivo MRI data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: one shoot at the surgery
The diagnostic performance of the radiomic and multiomic algorithm for the characterization of heterogeneity in the CSOHG.
one shoot at the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the imaging phenotype of tumor heterogeneity with a multi-scale radiomic approach by obtaining the image mirror tumor at the in vivo scale
Time Frame: one shoot at the surgery
Correlation between radiomic maps and pathogenic maps of heterogeneity,
one shoot at the surgery
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
Time Frame: one shoot at the surgery
Correlation between radiomic algorithms and i/underlying histology and ii/ genomics
one shoot at the surgery
the heterogeneity of the tumor biology of CSOHG through non-invasive habitat imaging combined with an integrated Multi-O-Mics approach.
Time Frame: one shoot at the surgery
Correlation between radiomic maps and tumor biology (CYTOF, proteomics and transcriptomics),
one shoot at the surgery
To Correlate MRI results with hematological molecular biology results.
Time Frame: one shoot at the surgery
Correlation between radiomic algorithms for tumor detection and cDNA determination.
one shoot at the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Director: NOUGARET Stephanie, MD, INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2023-02 MRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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