NCT07883551Not yet recruiting
AI Analysis of CT Scans to Classify Ovarian Tumours as Benign, Borderline or Malignant Before Surgery
Foundation Model-based AI for Preoperative Three-class Ovarian Tumour Classification: Using Computer Aided Diagnosis (CADx) to Predict Whether an Ovarian Tumour is Benign, Malignant or Borderline
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
The goal of this observational study is to learn if a computer program can tell what type of ovarian tumour a person has from a CT scan taken before surgery. The program uses artificial intelligence (AI). It sorts tumours into three groups: * benign: not cancer * borderline: abnormal cells that usually behave less aggressively than cancer * malignant: cancer Before surgery, doctors try to judge which group a tumour belongs to. This guides where and how the operation is done. This judgement is often hard, especially for borderline tumours. An AI program that does it well could help doctors plan surgery. The main questions it aims to answer are: * How well does the AI program sort ovarian tumours into benign, borderline and malignant on CT scans? * Does the AI program work as well on scans from hospitals it did not learn from? Researchers will compare the AI program's results with the final diagnosis from the tumour tissue removed during surgery. They will also compare the program with methods doctors use today, such as ultrasound-based risk scores and the radiologist's report. In a smaller group, researchers will test the program on MRI scans. This study only uses information that already exists. It includes adults who had surgery for a mass in or near the ovary at hospitals in the Netherlands and Belgium. Researchers will use: * CT or MRI scans made before surgery as part of regular care * information from medical records * the tissue diagnosis after surgery Participants will not be contacted. They will not have any extra scans, tests or visits. Each hospital codes the data before sharing them, so researchers cannot see participants' names. The study does not change anyone's care.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1300 (estimated)
- First submitted
- 9 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Oct 2031
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Diseases
- Ovarian cancer
- NCT number
- NCT07883551
What you commit to
- Study type: Observational
- Planned participants: 1300
- From Nov 2026 to the primary completion date, Oct 2031
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ovarian malignancy or prior oncological treatment affecting the adnexal region
Other illness
- Extra-ovarian disease that prevents reliable identification or attribution of the adnexal lesion as the index tumour (for example diffuse peritoneal carcinomatosis or a confirmed non-ovarian primary malignancy)
Other
- No definitive postoperative histopathology available
- Imaging of insufficient diagnostic quality (for example incomplete series, corrupted files or non-diagnostic sequences)
- Pathology report judged indefinite or inconclusive by the reviewing clinician
Who the study is looking for
- Age 18 years or older at the time of imaging
- Ovarian or adnexal mass on clinical and/or radiological assessment that can be reliably identified as the index lesion on CT and/or MRI
- Preoperative CT and/or MRI scan available, acquired as part of routine clinical care
- Surgical removal of the ovarian or adnexal mass, with definitive postoperative histopathology available as reference standard
- Bilateral ovarian tumours are eligible. If histopathology differs between sides, a predefined rule is applied (for example, selection of the lesion with the highest malignant potential)
- Advanced ovarian malignancy, including ascites or peritoneal disease, is eligible if the primary adnexal mass can be clearly identified on imaging
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Amsterdam University Medical Centre Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Netherlands Cancer Institute-Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Amphia Ziekenhuis Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Leiden University Medical Centre Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.