Gynecological Ultrasound Image Bank for Diagnostics and AI
Ultrasound Image Bank: Advancing Medical Research and Diagnostics
This project will collect gynecological ultrasound images from adult patients at a Rome hospital to build a large database for clinician training, research, and AI diagnostic tools.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT07031921 on ClinicalTrials.gov |
What this trial studies
This prospective, observational, single-center project plans to enroll about 25,000 adult patients undergoing gynecological ultrasound at Fondazione Policlinico Gemelli over five years. Images will be collected during routine clinical care from people with no disease, benign conditions, or suspected malignancy. For patients who undergo surgery within three months, images will be linked to histological outcomes, and others will be linked to one-year follow-up scans to provide outcome references. The dataset will be used to support medical training, clinical research, and development and validation of AI-based diagnostic tools.
Who should consider this trial
Good fit: Adults (≥18 years) examined at the Class Ultrasound OMIC unit of Fondazione Policlinico Gemelli who sign informed consent are eligible for enrollment regardless of ultrasound findings.
Not a fit: People under 18, those who do not give informed consent, and patients who cannot attend this single-center site are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the database could improve early and more accurate diagnosis of gynecological conditions by enhancing training and enabling better AI decision-support tools.
How similar studies have performed: Other medical imaging banks and AI projects have demonstrated promise in improving diagnostic accuracy, but similarly large, standardized gynecologic ultrasound datasets remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients examined at Class Ultrasound OMIC of Fondazione Policlinico Gemelli, IRCCS in Rome. * All patients can be enrolled regardless the results of ultrasound examination: no evidence of disease, suspicion of benign or malignant pathologies * Aged ≥ 18 years old * Patients who were previously enrolled and their outcome has been completed * Signature of informed consent Exclusion Criteria: * No signed informed consent;
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Antonia Carla Testa — Fondazione Policlinico Universitario Agostino Gemelli
- Study coordinator: Antonia Carla Testa
- Email: antoniacarla.testa@policlinicogemelli.it
- Phone: 0630156399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.