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RECRUITING
NCT06675266

AIRFRAME: Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs at Second Trimester Fetal Brain Scan

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

Obstetric ultrasound represents the standard of care for the screening of the fetal anomalies. However, its performance is dependent upon several parameters including type of anomaly, gestational age, maternal habitus and skills of the examiner. The use of Artificial Intelligence (AI) in medical diagnostics has been suggested not only to reduce the inter- and intra-operator variability, but also to compress the required time necessary to perform routine tasks, hence optimizing healthcare resources. Fetal brain abnormalities are among the most challenging fetal congenital anomalies in terms of ultrasound diagnosis, prenatal counseling and management. The access to new sources of technology, i.e. AI, has the potential to improve recognition, detection and localization of brain malformations. Therefore, we propose to develop an AI-based software, which would be capable to recognize the brain structures at antenatal ultrasound and discriminate between normal and abnormal fetal brain anatomy through fully automatic data processing.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2023-04-30

Completion Date

2026-12-30

Last Updated

2024-11-05

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Development of AI algorithm for early detection of fetal brain anomalies in the second trimester screening scan

Development of AI algorithm for early detection of fetal brain anomalies in the second trimester of pregnancy

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Italy