Ovarian Cancer Radiomics Approach in CT Led Evaluation
ConditionOvarian Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorImperial College Healthcare NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
168 Participants
are grouped into 1 trial groupGroup A: Suspected / confirmed advanced epithelial ovarian cancer
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College Healthcare NHS Trust
Lead sponsor
National Cancer Center, Korea
Collaborator
Source ClinicalTrials.gov