Ultrasound Image Bank: Advancing Medical Research and Diagnostics

NCT07031921 | Recruiting

• 1 other identifier: 7692
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Imaging; Ultrasound Diagnostics; Gynecologic Disease

Keywords

Ultrasound Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

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

  Up to 12 months after initial ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who come to undergo an ultrasound examination at the Class Ultrasound OMIC Center fulfilling the inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• No signed informed consent;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Antonia Carla Testa

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Carla Testa

CONTACT

0630156399; antoniacarla.testa@policlinicogemelli.it

Francesca Moro

CONTACT

0630156399; francesca.moro@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 22, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2030
• Last Updated: March 12, 2026

Record last verified: 2025-05

Locations

IT (1)