Ultrasound Image Bank: Advancing Medical Research and Diagnostics

N/ANot Yet RecruitingNCT07031921

Fondazione Policlinico Universitario Agostino Gemelli IRCCS25,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

25,000

Conditions

Gynecological Imaging Ultrasound Diagnostics Gynecologic Disease

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Establishment of a digital ultrasound image biobank 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.

Time frame: Up to 12 months after initial ultrasound examination (including follow-up data)

Secondary Outcomes

Percentage of enrolled patients with complete follow-up data (histological results or 1-year ultrasound)

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.

Time frame: Up to 12 months after initial ultrasound examination