Clinical trial NCT06084195: Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
Official title: Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Grade Serous Ovarian Cancer
Keywords: Radiomics
Ovarian cancer
Genomics
Proteomics
Immune Tumor Microenvironment
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: one shoot at the surgery
Secondary outcomes:
measure: the imaging phenotype of tumor heterogeneity with a multi-scale radiomic approach by obtaining the image mirror tumor at the in vivo scale
timeFrame: one shoot at the surgery
measure: 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
timeFrame: one shoot at the surgery
measure: the heterogeneity of the tumor biology of CSOHG through non-invasive habitat imaging combined with an integrated Multi-O-Mics approach.
timeFrame: one shoot at the surgery
measure: To Correlate MRI results with hematological molecular biology results.
timeFrame: one shoot at the surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: NOUGARET Stephanie
Study officials:
affiliation: INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
name: NOUGARET Stephanie, MD
role: STUDY_DIRECTOR
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