AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting
研究概览
简要总结
The goal of this clinical trial is to verify the opportunistic screening potential of the AI software for detection of brain unruptured intracranial aneurysms (UIA) on routinely performed brain NECT scans in a prospective setting in the Belgian population.
The main question the study aims to answer is: Does the AI algorithm has potential to be used as clinical screening potential for detection of brain UIA on brain NECT scans?
The performance and the clinical use of the AI algorithm will be measured based on the number of UIA detected by the AI software compared to the number of UIA confirmed by review of a radiologist compared to the number of UIA already known by review of the electronic patient file/additional diagnostic research.
Participants will be followed-up following Standard-of-Care (SoC). In addition, participants will be requested to complete a questionnaire (the EQ-5D-5L questionnaire).
Furthermore, patient outcomes, complications/death related to the possible (un)ruptured brain aneurysm will be assessed 5 years after study enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •the subject of the NECT scan must be an adult patient (Age ≥ 18 years old);
- •the NECT scan must be a NECT scan from the brain;
- •the NECT scan must contain the entire brain
- •the patient should have at least one of the following risk factors for developing a brain aneurysm
- •patient is female
- •patient has a family history of brain aneurysms
- •patient is 40 years or older
- •patient has or is treated for a high blood pressure
- •patient actively smokes cigarettes at time of inclusion
- •a first informed consent form must be signed before brain NECT scans can be transferred to Robovision
- •a second signed written informed consent must be obtained before follow-up data will be gathered, if applicable.
排除标准
- •- There are no specific exclusion criteria.
研究组 & 干预措施
Brain NECT scans with possible UIA detected by AI software and radiologist
Patients that have had a brain NECT scans on which the AI software detected a possible unruptured intracranial brain aneurysm (UIA) and which the radologist confirmed as possible UIA can participate in the study (= enrolled subjects). They are requested to sign Informed Consent Form (ICF) after which follow-up data regarding the untruptured intracranial aneurysm (UIA) will be gathered.
干预措施: AI software (Device)
结局指标
主要结局
Verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting
时间窗: an average of 1 month after subject enrolment
次要结局
- Verify the percentage of patients that underwent treatment(s) of the UIA after detection of the possible UIA by the AI software, confirmation of possible UIA by the radiologist, and definitive diagnosis of the UIA, by review of the EPD.(Through study completion, an average of 5 years.)
- Measure the health-related quality of life of patients by completion of the EQ-5D-5L questionnaire.(From start patient recruitment until 1 month after last patient signed ICF. Questionnaire to be completed 1 months after signing ICF.)
- Verify patients' complications by review of the EPD after 5 years(5 years after patient enrolment.)