ClinicalTrials.gg
RecruitingNCT06817174ORACLEUpdated Jun 27, 2025

Ovarian Cancer Radiomics Approach in CT Led Evaluation

An observational study in Ovarian Cancer, sponsored by Imperial College Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.

Primary conditionCarcinoma, Ovarian EpithelialRegistry: Ovarian NeoplasmsReclassifiedWhy we changed it
Registry
Ovarian Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Ovarian Epithelial
Why
  1. The study's title name Carcinoma, Ovarian Epithelial, a narrower term within Ovarian Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Imperial College Healthcare NHS Trust · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
168
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Ovarian Cancer

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Keywords

  • Ovarian cancer
  • Radiomics
  • CT
  • Prognosis
  • Epithelial ovarian cancer
  • Biomarkers
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In context

Carcinoma, Ovarian Epithelial Reclassified

797 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 101 are open to participants now.

This study's planned enrollment of 168 is below the median of 200 across 91 observational studies indexed under Carcinoma, Ovarian Epithelial.

Browse Carcinoma, Ovarian Epithelial studies →

Lead sponsor

Imperial College Healthcare NHS Trust is the lead sponsor of 80 studies on the registry; 19 are open to participants now.

Compared within Carcinoma, Ovarian Epithelial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ovarian Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population will consist of patients from Imperial College Healthcare Trust, London, UK and National Cancer Centre, Korea, diagnosed with ovarian masses suspected or confirmed as advanced epithelial ovarian cancer. Participants must be medically fit to undergo the combination of cytoreductive surgery and platinum-based chemotherapy, as part of their standard anticancer treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written (signed and dated)
  • 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 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

Exclusion Criteria:

  • Known to CT with IV contrast (e.g. contrast allergy, renal failure, inability to lie flat);
  • Unable to give ;
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
168 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Suspected / confirmed advanced epithelial ovarian cancer
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What researchers measure

Primary outcomes

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

    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

    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.

Secondary outcomes

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

    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

    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.

Other outcomes

  1. Correlating radiomics model with BRCA and HRD

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

  2. Radiogenomic evaluation

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

    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.

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Kristofer Linton-Reid, Georg Wengert, Haonan Lu, Christina Fotopoulou, Philippa Lee, Federica Petta, Luca Russo, Giacomo Avensani, Murbarik Arshard, Philipp Harter, Mitch Chen, Marc Boubnovski, Sumeet Hindocha, Ben Hunter, Sonia Prader, Joram M. Posma, Andrea Rockall, Eric O. Aboagye. End-to-End Integrative Segmentation and Radiomics Prognostic Models Improve Risk Stratification of High-Grade Serous Ovarian Cancer: A Retrospective Multi-Cohort Study. medRxiv 2023.04.26.23289155; doi: https://doi.org/10.1101/2023.04.26.23289155
  • Fotopoulou C, Rockall A, Lu H, Lee P, Avesani G, Russo L, Petta F, Ataseven B, Waltering KU, Koch JA, Crum WR, Cunnea P, Heitz F, Harter P, Aboagye EO, du Bois A, Prader S. Validation analysis of the novel imaging-based prognostic radiomic signature in patients undergoing primary surgery for advanced high-grade serous ovarian cancer (HGSOC). Br J Cancer. 2022 Apr;126(7):1047-1054. doi: 10.1038/s41416-021-01662-w. Epub 2021 Dec 18. PubMed 34923575 ↗
  • Lu H, Arshad M, Thornton A, Avesani G, Cunnea P, Curry E, Kanavati F, Liang J, Nixon K, Williams ST, Hassan MA, Bowtell DDL, Gabra H, Fotopoulou C, Rockall A, Aboagye EO. A mathematical-descriptor of tumor-mesoscopic-structure from computed-tomography images annotates prognostic- and molecular-phenotypes of epithelial ovarian cancer. Nat Commun. 2019 Feb 15;10(1):764. doi: 10.1038/s41467-019-08718-9. PubMed 30770825 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Jan 2032, 83 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2025
First posted
Feb 10, 2025
StartActual
Feb 10, 2025
Primary completionEst.
Jan 2032
CompletionEst.
Jan 2032
Last update
Jun 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06817174
Lead sponsor
Imperial College Healthcare NHS Trust
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
Feb 10, 2025
Primary completion
Jan 2032 (estimated)
Completion
Jan 2032 (estimated)
Last update
Jun 27, 2025

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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