A Retrospective Multicenter Clinical Performance Study of RDX-Aneurysm for Detecting Saccular Intracranial Aneurysms on Adult Head TOF-MRA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
- 试验地点
- 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.