NCT06675266 AIRFRAME: Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs at Second Trimester Fetal Brain Scan
| NCT ID | NCT06675266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Fetal Anomalies |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2023-04-30 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2023-04-30 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Alessandra Familiari
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06675266 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Fetal Anomalies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06675266 currently recruiting?
Yes, NCT06675266 is actively recruiting participants. Contact the research team at alessandra.familiari@policlinicogemelli.it for enrollment information.
Where is the NCT06675266 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06675266 clinical trial?
NCT06675266 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Alessandra Familiari at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 10,000 participants.