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NCT Number: NCT06817174

Ovarian Cancer Radiomics Approach in CT Led Evaluation

When patients have suspected or confirmed ovarian cancer standard treatment will involve surgery and chemotherapy. However, as with any treatment, it is challenging to predict treatment response in advance. Before treatment, all patients have a CT scan to describe where the cancer is in order to guide the treatment.

There is now a new way to analyse routine scans using advanced computing methods, which may give more information about the ovarian cancer. This is called radiomics which analyses features in scans that are not visible to the naked eye. Our group at Imperial College London has worked on developing radiomic models to better understand ovarian cancer.

This study aims to determine whether the information gained from this new approach would help us to tailor patient treatment plans to better meet the patient's individual needs, even more than done already. Furthermore, the aim is to understand how different types of ovarian cancer can correlate with the radiomic findings, which may help develop potential treatments in the future.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial 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 Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written (signed and dated) informed consent
  • Age 18 years or over
  • Suspected or confirmed advanced epithelial ovarian cancer (FIGO stage 3B or more)
  • Being considered for active anticancer treatment i.e. primary cytoreductive surgery followed by chemotherapy or neoadjuvant chemotherapy followed by interval cytoreductive surgery
  • Evaluable baseline portal venous phase CT scan prior to surgical or medical treatment for ovarian cancer
  • Disease visible on pre-treatment portal venous phase baseline CT scan (≥2cm)

Exclusion criteria

  • Known contra-indication to CT with IV contrast (e.g. contrast allergy, renal failure, inability to lie flat);
  • Unable to give informed consent;
  • Known pregnancy;
  • No visible disease <2cm on portal venous phase baseline CT scan;
  • Previous surgery for resection of an adnexal mass;
  • Significant artefact on CT image for example from metal prostheses that precluded meaningful segmentation of visible disease
  • Only fit for palliative care at initial presentation

Treatment and study plan

Primary outcomes

  1. Comparison of CT-based Radiomics Models and Clinical Model in Predicting Progression-Free Survival Post-Cytoreductive Surgery in Ovarian Cancer

    Time frame: From enrolment to approximately 5 years after the last patient is enrolled, based on the final data capture at the end of follow-up.

    Comparison of each CT-based radiomics model concordance index to predict progression free survival against the clinical model following cytoreductive surgery in the primary or interval setting.

    Comparisons:

    i. Manual CT radiomics model to the clinical model alone ii. Automated CT radiomics model to the clinical model alone

Secondary outcomes

  1. Comparison of CT-Radiomics Models and Clinical Model in Predicting Overall Survival Post-Cytoreductive Surgery in Ovarian Cancer

    Time frame: From enrolment to approximately 5 years after the last patient is enrolled, based on the final data capture at the end of follow-up.

    Comparison of each CT-based radiomics model concordance index to predict overall survival against the clinical model following cytoreductive surgery in the primary or interval setting.

    Comparisons:

    i. Manual CT radiomics model to the clinical model alone ii. Automated CT radiomics model to the clinical model alone

Other outcomes

  1. Correlating radiomics model with BRCA and HRD

    Time frame: From enrolment to approximately 5 years after the last patient is enrolled, based on the final data capture at the end of follow-up.

    Correlation of each radiomics model with clinically approved biomarkers BRCA and HRD status in advanced epithelial ovarian cancer.

  2. Radiogenomic evaluation

    Time frame: From enrolment to approximately 5 years after the last patient is enrolled, based on the final data capture at the end of follow-up.

    Evaluate the biological basis for different thresholds of radiomic scores (manual and automated) using molecular analysis of fresh tumour specimens and blood samples.

Study contacts

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

Christina Fotopoulou, MD, PhD

CONTACT

[email protected]

(+44) +44 (0)20 3313 3274

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Collaborators

  • National Cancer Center, Korea

Registry information

Official study title

Prospective Validation of CT Based Radiomic Models to Predict Surgical and Clinical Outcomes in Advanced Epithelial Ovarian Cancer

Acronym: ORACLE

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Feb 10, 2025
Registry last updated
Jun 27, 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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