Using AI to detect fetal brain anomalies during second trimester ultrasounds
Official title: Development of an Artificial Intelligence Algorithm to Recognize Abnormal Findings at Routine Fetal Brain Ultrasound. AIRFRAME (Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs)
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06675266 · Data updated 2026-11-12
This study is testing a new AI software to see if it can help doctors find brain problems in babies during second trimester ultrasounds.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 10000 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | April 30, 2023 |
| Main results expected | December 30, 2024 |
| Study ends | December 30, 2026 |
| Registry record updated | November 5, 2024 |
| Trial ID | NCT06675266 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women with singleton pregnancies who are undergoing ultrasound examinations between 19 and 22 weeks of gestation.
✕Probably not a fit
Patients who do not have a clear visualization of the fetal brain structures during the ultrasound or who cannot provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to develop and validate an AI-based software designed to recognize fetal brain structures and identify abnormalities during second trimester ultrasound scans. The study will be conducted in two phases: a retrospective phase to train the AI algorithm using previously acquired ultrasound images, followed by a prospective phase to test the algorithm in real clinical settings. The goal is to enhance the accuracy and efficiency of fetal brain anomaly detection, ultimately improving prenatal care and management.
Why it matters
Potential benefit: If successful, this AI technology could significantly improve the early detection of fetal brain anomalies, leading to better prenatal counseling and management.
How similar studies have gone: While the application of AI in medical diagnostics is gaining traction, this specific approach to fetal brain anomaly detection is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with singleton pregnancies undergoing ultrasound examination between 19+0 - 22+6 weeks of gestation Exclusion Criteria: * Women who did not have the second trimester screening scan at the settled gestational age. * Women in which a good visualization of the transventricular, transthalamic and transcerebellar plane of the fetal head was not technically possible. * Women who are not able to give the informed consent.
Where it's running
-
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy Recruiting
Study contacts
- Principal investigator: Alessandra Familiari — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Alessandra Familiari, MD
- Email: alessandra.familiari@policlinicogemelli.it
- Phone: +39 3285887422
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.