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NCT06675266: AIRFRAME
AIRFRAME: Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs at Second Trimester Fetal Brain Scan
trial testing Development of AI algorithm for early detection of fetal brain anomalies in the second trimester screening scan in Fetal Anomalies in 10,000 participants. Currently enrolling.
30 December 2024
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 10,000 |
| Start date | 30 April 2023 |
| Primary completion | 30 December 2024 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Development of AI algorithm for early detection of fetal brain anomalies in the second trimester screening scan
Conditions studied
- Fetal Anomalies — all drugs for Fetal Anomalies →
- Brain Malformation — all drugs for Brain Malformation →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 18 to 60, female only, with Fetal Anomalies or Brain Malformation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06675266
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06675266 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 5 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06675266.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing