Ultrasound Image Bank: Advancing Medical Research and Diagnostics

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07031921

Acronym

Ultra-Bank

Enrollment

25000

Registered

2025-06-22

Start date

2025-06-25

Completion date

2030-05-30

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Imaging, Gynecologic Disease, Ultrasound Diagnostics

Keywords

Ultrasound Imaging

Brief summary

The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. These images will be collected during routine clinical care from both healthy patients and those with benign or malignant gynecological conditions. The goal is to support medical training, clinical research, and the development of artificial intelligence (AI) models for diagnostic purposes. This is a prospective, observational, single-center study, with an expected enrollment of approximately 25,000 patients over five years. The ultrasound images will be linked to histological outcomes (for those undergoing surgery within 3 months) or to follow-up scans at 1 year, to enhance early diagnosis and personalized treatment approaches.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Establishment of a digital ultrasound image biobank including follow-up data	Up to 12 months after initial ultrasound examination (including follow-up data)	Systematic prospective collection and storage of 2D ultrasound images and video clips from patients undergoing gynecological ultrasound examinations. Each record will be associated with follow-up data, including histological results (within 3 months post-surgery, if applicable) and/or ultrasound re-evaluation (at 1-year follow-up). The goal is to generate a comprehensive image biobank for future research, including artificial intelligence studies.

Secondary

Measure	Time frame	Description
Percentage of enrolled patients with complete follow-up data (histological results or 1-year ultrasound)	Up to 12 months after initial ultrasound examination	Proportion of patients for whom follow-up data are available, defined as histological examination results within 3 months for those undergoing surgery, or ultrasound follow-up findings at 1 year for those not undergoing surgery.

Countries

Italy

Contacts

CONTACTAntonia Carla Testa

antoniacarla.testa@policlinicogemelli.it0630156399

CONTACTFrancesca Moro

francesca.moro@guest.policlinicogemelli.it0630156399

PRINCIPAL_INVESTIGATORAntonia Carla Testa

Fondazione Policlinico Universitario Agostino Gemelli

Outcome results