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Ovarian Cancer Radiomics Approach in CT Led Evaluation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06817174
Acronym
ORACLE
Enrollment
168
Registered
2025-02-10
Start date
2025-02-10
Completion date
2032-01-31
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian cancer, Radiomics, CT, Prognosis, Epithelial ovarian cancer, Biomarkers

Brief summary

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.

Interventions

None listed

Sponsors

National Cancer Center, Korea
CollaboratorOTHER_GOV
Imperial College Healthcare NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of CT-based Radiomics Models and Clinical Model in Predicting Progression-Free Survival Post-Cytoreductive Surgery in Ovarian CancerFrom 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

MeasureTime frameDescription
Comparison of CT-Radiomics Models and Clinical Model in Predicting Overall Survival Post-Cytoreductive Surgery in Ovarian CancerFrom 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

MeasureTime frameDescription
Correlating radiomics model with BRCA and HRDFrom 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.
Radiogenomic evaluationFrom 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.

Countries

United Kingdom

Contacts

Primary ContactChristina Fotopoulou, MD, PhD
c.fotopoulou@imperial.ac.uk(+44) +44 (0)20 3313 3274

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026