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AI eye on brain bulges: software aims to spot hidden aneurysms

NCT ID NCT07655635

Diagnosis Sponsor: Taipei Medical University Shuang Ho 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 evaluates RDX-Aneurysm, a computer-assisted detection software designed to help radiologists find saccular intracranial aneurysms (bulging blood vessels in the brain) on MRI scans. Researchers will analyze 550 past scans—half with confirmed aneurysms and half without—to see how accurately the software marks suspicious spots. The goal is to measure how many aneurysms it catches and how often it raises false alarms. This is a retrospective study using existing images, so the results do not affect patient care directly.

What this could mean

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

Active substance
RDX-Aneurysm (computer-assisted detection software)
What this could lead to
If successful, this software could help doctors spot brain aneurysms more reliably on routine MRI scans, potentially catching dangerous bulges before they rupture.
What could go wrong
This is a retrospective study using old scans, not a real-world test. The software may produce false alarms or miss some aneurysms, and results may not apply to all patients or scanners.

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 550 people

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

Started

Jul 2024

Expected to finish

Jun 2027

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

The study population consists of adults aged 18 years or older who underwent head TOF-MRA as part of clinical care or voluntary health screening. No race or ethnicity restrictions are applied. The retrospective dataset will include positive and negative TOF-MRA examinations selected according to predefined eligibility, image-quality, and technical requirements. Age distribution is planned at approximately 20-40 years, 10±10%, 40-60 years, 60±10%, and over 60 years, 30±10%. The planned sex ratio is approximately 1:1.2 to 1:2 (male: female), consistent with the protocol-defined sampling structure.

Ages

18 years and older

Sex

Anyone

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: 1. Adult subjects aged 18 years or older at the time of imaging. 2. Underwent head MRA, including TOF-MRA, as part of clinical care or voluntary health screening. 3. TOF-MRA images are available in DICOM format and meet the predefined study image-quality and technical requirements for retrospective analysis. Exclusion Criteria: 1. MRI-related contraindications documented in the available record or imaging context, including implanted pacemaker or defibrillator, cochlear implant, neurostimulator, intraocular or intracranial metallic foreign body, or other physician-determined MRI-unsuitable condition. 2. Clinically diagnosed intracranial hemorrhage, including intracerebral hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or epidural hemorrhage. 3. Clinically diagnosed arteriovenous malformation or arteriovenous fistula. 4. Prior intracranial aneurysm treatment, including surgical clipping or endovascular treatment, intracranial arterial stent placement, or craniotomy, where post-treatment structural changes may affect software interpretation. 5. Severe imaging artifact, incomplete image data, or image quality insufficient for reliable retrospective analysis. 6. Image data format or technical parameters not compatible with study analysis requirements.

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Conditions

The condition(s) this trial relates to.

brain aneurysm intracranial berry aneurysm

As listed by the trial registrant

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

Intracranial aneurysm

Contacts and locations

Locations

  • E-Da Hospital

    Kaohsiung City, 82445, Taiwan

  • Far Eastern Memorial Hospital

    New Taipei City, 220, Taiwan

  • Mackay Memorial Hospital Taitung Branch

    Taitung, 95054, Taiwan

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