Clinical Research Directory

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

Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Official title: A Retrospective Multicenter Clinical Performance Study of RDX-Aneurysm for Detecting Saccular Intracranial Aneurysms on Adult Head TOF-MRA

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