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AI reads baby brain scans: could it spot problems doctors miss?

NCT ID NCT07261618

Diagnosis Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing an artificial intelligence tool called Alyssia that analyzes 2D ultrasound images of the fetal brain. The goal is to see if the AI can accurately tell the difference between normal and abnormal brain findings, especially in the lateral ventricles. Researchers will use 800 archived images from routine prenatal scans (18-24 weeks) and compare the AI's results to expert assessments. If it works, this could help standardize diagnosis and reduce mistakes caused by differences in doctor experience or image quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Artificial intelligence-based diagnostic tool (Alyssia)
What this could lead to
If successful, this AI tool could help doctors spot fetal brain problems more reliably and earlier, leading to better prenatal care and outcomes.
What could go wrong
This is a retrospective study using archived images, not a real-world test. The AI may not perform as well in live clinical settings or with different image quality.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will use archived and anonymized 2D fetal brain ultrasound images obtained during routine prenatal screening examinations conducted between the 18th and 24th weeks of gestation. The dataset represents a diverse population of pregnant individuals aged 18-45 years who underwent standard obstetric ultrasound evaluations. All images were acquired as part of routine clinical care and stored in the institutional digital archive. Only diagnostically adequate images clearly displaying the lateral ventricles and other intracranial regions were included. The study population therefore consists of ultrasound records rather than direct human participants, ensuring complete anonymity and protection of personal data.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Archived 2D fetal brain ultrasound images obtained during routine prenatal examinations. * Gestational age between 18 and 24 weeks at the time of imaging. * Maternal age between 18 and 45 years. * Clear visualization of the lateral ventricles and other intracranial regions. * Images meeting diagnostic quality standards suitable for analysis. * Fully anonymized images with no patient identifiers. * Availability of expert assessment to classify each image as normal or abnormal. Exclusion Criteria: * Ultrasound images with poor diagnostic quality or motion artifacts. * Incomplete, duplicate, or corrupted image records. * Ambiguous gestational age or missing clinical metadata. * Images containing any identifiable patient information. * Cases outside the specified gestational window (before 18 or after 24 weeks). * Images unrelated to the fetal brain (misfiled or mislabeled data).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Artificial intelligence Intracranial anomalies Ultrasound imaging

Contacts and locations

Locations

  • Nefise nazlı Yenigül

    Bursa, Turkey (Türkiye)

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