Medical-AI trial: detecting brain aneurysms from head MRI (TOF-MRA) with AI (RDX-Aneurysm) — testing performance against misses (NCT07655635)

1What a missed brain aneurysm costs

A brain (intracranial) aneurysm is a balloon-like bulge in the wall of a brain vessel; most are asymptomatic, but a rupture causes the serious event of subarachnoid hemorrhage. Found before rupture, it can be watched or treated preventively. TOF-MRA, a form of brain MRI that depicts vessels from blood flow without contrast, is used to find aneurysms, but small or ambiguous ones are easily missed.

That is where computer-assisted detection (CADe) software, which analyzes the image and points to suspected aneurysm sites, comes in.

2A retrospective, multicenter performance study

This study evaluates the performance of that CADe software, RDX-Aneurysm, as a retrospective, multicenter, case-control study.

Per the registry summary, it evaluates the standalone performance of RDX-Aneurysm in detecting and marking suspected saccular (sac-like) intracranial aneurysms on adult head TOF-MRA. The evaluation includes about 550 exams: roughly 250 positive exams with at least one reference-confirmed saccular aneurysm 3 mm or larger, and roughly 300 negative exams with no confirmed aneurysm. The primary outcome is lesion-level sensitivity for saccular aneurysms 3 mm or greater.

3Positive and negative cases collected separately

The study takes a case-control design, gathering positive and negative cases separately in advance. The breakdown shows the character of the design.

The primary endpoint is lesion-level sensitivity for saccular intracranial aneurysms of 3 mm or more. Most aneurysms are asymptomatic, while rupture brings subarachnoid haemorrhage. TOF-MRA is used to find them, and small ones or confusing locations are easily missed, so AI marking suspicious sites could act as a second pair of eyes.