Clinical Performance Evaluation of RDX-Aneurysm for Detecting Intracranial Aneurysms on TOF-MRA
Key facts
- Who runs it
- Taipei Medical University Shuang Ho Hospital
- Where
- Taiwan3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 550 people, planned
- Started
- 20 Jul 2024
- Expected to end
- 30 Jun 2027
- Type of study
- Observational, 2 groups
- Record updated
- 18 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Adult subjects aged 18 years or older at the time of imaging
- Underwent head MRA, including TOF-MRA, as part of clinical care or voluntary health screening
- TOF-MRA images are available in DICOM format and meet the predefined study image-quality and technical requirements for retrospective analysis
Who cannot take part
- 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
- 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
- Clinically diagnosed intracranial hemorrhage, including intracerebral hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or epidural hemorrhage
- Clinically diagnosed arteriovenous malformation or arteriovenous fistula
- Severe imaging artifact, incomplete image data, or image quality insufficient for reliable retrospective analysis
- Image data format or technical parameters not compatible with study analysis requirements
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This retrospective, multi-center, observational case-control study evaluates the standalone performance of RDX-Aneurysm, a computer-assisted detection software, for detecting and marking suspected saccular intracranial aneurysm locations on adult head time-of-flight magnetic resonance angiography (TOF-MRA). Approximately 550 evaluable examinations will be included, consisting of approximately 250 positive examinations with at least one reference-standard-confirmed saccular intracranial aneurysm measuring 3 mm or greater and approximately 300 negative examinations with no reference-standard-confirmed intracranial aneurysm. The primary outcome is lesion-level sensitivity for detecting reference-standard-confirmed saccular intracranial aneurysms measuring 3 mm or greater. The secondary outcome is false positives per scan. This study uses existing retrospective imaging data only; study outputs are not returned to clinical care and do not affect patient diagnosis, treatment, or follow-up.
The 2 groups in the trial
- Positive TOF-MRA Cohort
Adult head TOF-MRA examinations with at least one reference-standard-confirmed saccular intracranial aneurysm measuring 3 mm or greater.
- Negative TOF-MRA Cohort
Adult head TOF-MRA examinations with no reference-standard-confirmed intracranial aneurysm.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Retrospective Multicenter Clinical Performance Study of RDX-Aneurysm for Detecting Saccular Intracranial Aneurysms on Adult Head TOF-MRA
- Record updated
- 18 June 2026