Clinical trial NCT06675266: AIRFRAME: Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs at Second Trimester Fetal Brain Scan
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fetal Anomalies
Brain Malformation
Keywords: Fetal Brain Anomaly
Brain Malformation
Second trimester ultrasound Scan
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Ospedale Di Venere - Carbonara di Bari - Bari, Italy
name: Azienda Ospedaliero-Universitaria di Parma
First posted: 2024-11-05
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women undergoing second trimester screening scan in the participating centers who provide informed consent to enrolment

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.

Detailed description: The application of AI in obstetric ultrasound includes three aspects: structure identification, automatic and standardized measurements, and classification diagnosis. Since obstetric ultrasound is time-consuming, the use of AI could also reduce examination time and improve workflow.

Study design: this is a multicenter retrospective observational cohort study and subsequent prospective cohort study. The study design will be organized in two different phases.

The first phase, the feasibility retrospective study, has the objective to develop and train AI-Algorithm with normal and abnormal images retrospectively acquired during second trimester ultrasound scan from various international fetal medicine centers.

The second phase, a prospective clinical validation, has the objective to test the AI-Algorithm in the assessment of basic fetal brain anatomy in a real clinic setting with real patients from each of the participating fetal medicine centers.

Setting: Three (3) fetal medicine centers.

Participants: singleton pregnant population who underwent ultrasound examination between 19 - 22 weeks of gestation in the participating centers.

Primary endpoint: to validate a novel AI-based technology for the automated assessment of the basic anatomy of the fetal brain which could potentially be used to support second trimester screening scan.

Secondary endpoints:

To improve the performance of the standard second trimester screening of fetal brain anatomy ensuring its reliable sonographic assessment within a shorter time of execution.

To detect higher repeatability and reproducibility, allowing to implement the ultrasound screening also in terms of efficiency on a vast scale, optimizing healthcare resources In the first phase of the study, participating fetal medicine centers will search their electronic databases for images of singleton pregnant women who underwent ultrasound imaging at 19+0 - 22+6 weeks of gestation with any fetal brain anomaly. Normal images of the fetal brain at the same gestational age will be provided by the promoting centers - i.e., Fondazione Policlinico A. Gemelli, IRCCS and University of Parma. Clinical, ultrasound, prenatal and postnatal information of each case will be retrieved from patient's medical records and entered an electronic database collection file by the principal investigator from each participating center. The acquired images will be anonymized, saved as DICOM and shared through a dedicated cloud storage system which will be set up by the bioengineering team. Each center will be able to access the web system using a personal ID and password.

In the second phase of the study, the algorithm will be prospectively tested and validated in a real clinical setting with real patients from each of the participating fetal medicine centers. Inclusion and exclusion criteria, imaging protocol and data collection will be the same carried out during the retrospective phase.

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.

Primary outcomes:
measure: AI algorithm
timeFrame: 2 years
Secondary outcomes:
measure: Reproducibility
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Alessandra Familiari
role: PRINCIPAL_INVESTIGATOR
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