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NCT Number: NCT06084195

Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging

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

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Key information

Conditions

High Grade Serous Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NOUGARET Stephanie

Montpellier, 34298, France

Location status: Recruiting

Location contact

NOUGARET Stephanie, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample and tissue sample

Biological

During the surgery :

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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,

  2. 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

  3. 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),

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

MOUSSION Aurore

CONTACT

[email protected]

0467613102 ext. +33

Texier Emmanuelle

CONTACT

[email protected]

0467613102 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: MR-O-MICS

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Oct 16, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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