Intracranial AneurysmRDX-AneurysmNCT07655635
Clinical Performance Evaluation of RDX-Aneurysm for Detecting Intracranial Aneurysms on TOF-MRA
An observational study of Intracranial Aneurysm, run by Taipei Medical University Shuang Ho Hospital at 3 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 550 participants
- Where
- 3 sitesTaiwan
- Study dates
- 20 Jul 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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 join
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
E-Da Hospital
Kaohsiung City, 82445
Far Eastern Memorial Hospital
New Taipei City, 220
Mackay Memorial Hospital Taitung Branch
Taitung, 95054
About this study
Official title: A Retrospective Multicenter Clinical Performance Study of RDX-Aneurysm for Detecting Saccular Intracranial Aneurysms on Adult Head TOF-MRA
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.
Read the detailed description
Existing adult head TOF-MRA examinations from participating medical institutions will be selected according to pre-specified inclusion and exclusion criteria. A reference standard for aneurysm presence and lesion location will be established by qualified radiologists according to the study protocol. RDX-Aneurysm outputs will be generated on the locked retrospective image dataset and compared with the reference standard. The study evaluates only the standalone lesion-detection and marking function of the software. It does not evaluate triage, worklist prioritization, urgent notification, autonomous diagnosis, autonomous measurement or classification, rupture-risk prediction, treatment planning, or reader-performance improvement.
- Conditions
- Intracranial Aneurysm
- Keywords
- TOF-MRA, computer-assisted detection, medical image analysis, artificial intelligence
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion-level sensitivity for saccular intracranial aneurysms measuring 3 mm or greater
Lesion-level sensitivity is defined as the proportion of reference-standard-confirmed saccular intracranial aneurysm lesions measuring 3 mm or greater that are correctly detected and marked by RDX-Aneurysm. Sensitivity = TP / (TP + FN), where TP is a true-positive lesion-level detection and FN is a false-negative reference-standard-confirmed lesion not detected by the software.
Measured: Through study completion, an average of 3 years
Secondary outcomes (1)
False positives per scan
False positives per scan is defined as the average number of software-marked suspected aneurysm locations per TOF-MRA examination that do not correspond to a reference-standard-confirmed intracranial aneurysm lesion.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start20 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuei-Hung Kuo, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655635
- Sponsor's protocol ID
- 113166-F
- Other IDs
- MOHW114-IM-I-212-000004-4
- Acronym
- RDX-Aneurysm
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this retrospective study uses de-identified clinical imaging data obtained under institutional review board approvals and hospital data governance requirements. Raw DICOM images and subject-level clinical data are subject to privacy, ethical, and institutional restrictions and are not approved for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Clinical Performance Study of RDX-Aneurysm for Detecting Saccular Intracranial Aneurysms on Adult Head TOF-MRA
- ClinicalTrials.gov ID
- NCT07655635
- Acronym / sponsor ID
- RDX-Aneurysm / 113166-F
- Conditions
- Intracranial Aneurysm
- Keywords
- TOF-MRA, computer-assisted detection, medical image analysis, artificial intelligence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Existing adult head TOF-MRA examinations from participating medical institutions will be selected according to pre-specified inclusion and exclusion criteria. A reference standard for aneurysm presence and lesion location will be established by qualified radiologists according to the study protocol. RDX-Aneurysm outputs will be generated on the locked retrospective image dataset and compared with the reference standard. The study evaluates only the standalone lesion-detection and marking function of the software. It does not evaluate triage, worklist prioritization, urgent notification, autonomous diagnosis, autonomous measurement or classification, rupture-risk prediction, treatment planning, or reader-performance improvement.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lesion-level sensitivity for saccular intracranial aneurysms measuring 3 mm or greater
Time frame: Through study completion, an average of 3 years
Lesion-level sensitivity is defined as the proportion of reference-standard-confirmed saccular intracranial aneurysm lesions measuring 3 mm or greater that are correctly detected and marked by RDX-Aneurysm. Sensitivity = TP / (TP + FN), where TP is a true-positive lesion-level detection and FN is a false-negative reference-standard-confirmed lesion not detected by the software.
1 secondary outcome
False positives per scan
Time frame: Through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this retrospective study uses de-identified clinical imaging data obtained under institutional review board approvals and hospital data governance requirements. Raw DICOM images and subject-level clinical data are subject to privacy, ethical, and institutional restrictions and are not approved for public data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuei-Hung Kuo, MD principal investigator
Far Eastern Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Taipei Medical University Shuang Ho Hospital at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion-level sensitivity for saccular intracranial aneurysms measuring 3 mm or greater (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.