Clinical Performance Evaluation of RDX-Aneurysm for Detecting Intracranial Aneurysms on TOF-MRA (NCT07655635) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Performance Evaluation of RDX-Aneurysm for Detecting Intracranial Aneurysms on TOF-MRA
Taiwan550 participantsStarted 2024-07-20
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lesion-level sensitivity for saccular intracranial aneurysms measuring 3 mm or greater
Timeframe: Through study completion, an average of 3 years
Trial details
NCT IDNCT07655635
SponsorTaipei Medical University Shuang Ho Hospital
. Clinically diagnosed arteriovenous malformation or arteriovenous fistula.
. 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.
. 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.