Clinical Performance Evaluation of RDX-Aneurysm for Detecting Intracranial Aneurysms on TOF-MRA

NCT07655635 | Active Not Recruiting

• 2 other identifiers: 113166-FMOHW114-IM-I-212-000004-4
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Intracranial Aneurysm

Keywords

TOF-MRA; computer-assisted detection; medical image analysis; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 3 years

Secondary Outcomes (1)

• False positives per scan

  Through study completion, an average of 3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (3)

E-Da Hospital

Kaohsiung City, 82445, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Mackay Memorial Hospital Taitung Branch

Taitung, 95054, Taiwan

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kuei-Hung Kuo, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 18, 2026
• Study Start: July 20, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)