Ovarian Cancer Radiomics Approach in CT Led Evaluation (ORACLE)

Imperial College Healthcare NHS Trust

Status: Enrolling

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06817174

25/SC/0032

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

168 participants in 1 patient group

Suspected / confirmed advanced epithelial ovarian cancer