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NCT Number: NCT07031921

Ultrasound Image Bank: Advancing Medical Research and Diagnostics

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.

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Key information

Conditions

Gynecological Imaging Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynecologic Disease Ultrasound Diagnostics Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

ANTONIA CARLA TESTA, Professor

CONTACT

[email protected]

0630156399

Antonia Carla Testa, prof

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Establishment of a digital ultrasound image biobank including follow-up data

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Carla Testa

CONTACT

[email protected]

0630156399

Francesca Moro

CONTACT

[email protected]

0630156399

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: Ultra-Bank

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Jun 22, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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