Non-invasive Detection of Cerebral Aneurysm Recurrence after Endovascular Treatment Using Automated Image Processing

PROJECT SUMMARY Hemorrhage due to cerebral aneurysm rupture is a devastating condition with high mortality. For the more than 30,000 patients in the US who are diagnosed annually with an aneurysm, treatment consists of preventing rupture, and increasingly relies of endovascular techniques. However, treatment durability is unknown with recurrence estimated at 16-40% and the re-treatment of 10-20%. The current gold standard to ensure aneurysm obliteration is catheter-based digital subtraction angiography (DSA), an invasive method with significant side effects. Here, we propose an alternative that uses simple skull x-rays and automated image processing to identify patients who are high likelihood of recurrence and select them for further investigation. Development of this technique is the result of a collaboration between the Medical Innovations Company (MIC) and the UTHealth and Memorial Hermann Hospital (UTH/MHH). We plan to test the hypothesis that aneurysm recurrence can be detected using standard skull x-rays. In Aim 1, we will develop an automated computer algorithm that detects aneurysm recurrence after coiling. Data from an established cohort of patients treated at UTH/MHH. Automated computer analysis of the x-rays (at initial treatment and 6-month follow) will predict aneurysm recurrence using coil morphometry (size, shape, orientation). The algorithm will be trained by comparing it to the gold standard for follow up (DSA). In Aim 2, preliminary validation of algorithm performance will be tested in a novel dataset. A validation dataset (n=150) of similar patients treated with the same protocol as the training dataset will be processed using the automated algorithm. The performance of the algorithm will be assessed using receiver operator characteristics to determine optimal sensitivity/specificity. If successful, such an approach could stratify risk in patients and determine which should undergo angiography. Reducing utilization of angiography will significantly reduce complications and medical cost at an immense benefit to the public. This Phase I STTR grant will allow for algorithm development and testing prior to a Phase II application and broader clinical trials. The partnership between MIC and UTH/MHH combines experience commercializing medical software with clinical neurosurgery. CONFIDENTIAL- UTHEALTHPROJECT NARRATIVE Cerebral aneurysm rupture is a dreaded medical condition with high mortality; and while significant advances have been made in endovascular treatment and coiling of aneuryms, there is no consensus on long term clinical follow up. The academic partner has developed an innovative and low cost alternative to current strategies to monitor for aneurysm recurrence in patients treated with endovascular coiling using automated analysis of skull x-rays. The small business partner has assisted with optimization and validation of this algorithm and will provide support for a subsequent clinical trial. CONFIDENTIAL- UTHEALTH