NCT05383053已完成不适用
A Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Artificial Intelligence-based Computer Aided Diagnosis Software That Assists in Determining Whether or Not to Conduct Amyloid PET for the Diagnosis of Alzheimer's Disease by Predicting Amyloid PET Positivity Using MR Brain Images(Including T1 Weighted MRI and T2 FLAIR MRI) and Clinical Information (Age, Sex, APOE(apolipoproteinE) Genotype) in Mild Cognitive Impairment Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Explore predictive values(Clinical Specificity, %)
研究概览
简要总结
- Purpose of clinical trial; This clinical trial is designed to evaluate the effectiveness of 'NeuroAI' prediction accuracy compared to the amyloid PET test results by retrospectively collecting medical data of patients with mild cognitive impairment to evaluate the effectiveness of artificial intelligence-based brain image detection and diagnosis assistance software 'NeuroAI'.
- Participants; Patient with mild cognitive impairment
详细描述
- Clinical recruitment; Brain MR images (T1 weighted MRI+T2 FLAIR MRI) of patients who underwent clinical diagnosis for mild cognitive impairment and performed amyloid PET tests for suspected Alzheimer's disease.
- Target number of images; Total 227 (median dropout rate considered 10%; Positive*118, Negative**109)
*Positive: Amyloid PET Positive
**Negative: Amyloid PET Negative
- Selection criteria; Brain MR images of image providers suitable for all of the following selection criteria may be registered in this clinical trial.
- Among those diagnosed with mild cognitive impairment (MCI) in accordance with the International Working Group on Mild Cognitive Impairment criteria, those aged 50 or older on the MRI scan date.
- Those who have undergone 3D configurable 3T MRI (brain T1 weighted MRI* and T2 FLAIR MRI**) tests.
* 40-slice 2D T1 MRI scan: Plane shall be photographed with sagittal hippocampus.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brain MR images of image providers suitable for all of the following selection criteria may be registered in this clinical trial.
- •Among those diagnosed with mild cognitive impairment (MCI) in accordance with the International Working Group on Mild Cognitive Impairment criteria, those aged 50 or older on the MRI scan date.
- •Those who have undergone 3D configurable 3T MRI (brain T1 weighted MRI* and T2 FLAIR MRI**) tests.
- •* 40-slice 2D T1 MRI scan: Plane shall be photographed with sagittal hippocampus.
- •** 3-slice 2D T2-FLAIR MRI scan: Plane shall be taken by axial.
- •FBB (F-18 Florbetaben) amyloid PET test for suspected Alzheimer's mild cognitive impairment is positive or negative.
- •☞ Images diagnosed with clear cerebral matrix damage (e.g., brain tumor, cerebral infarction, brain damage, normal pressure hydrocephalus, encephalitis) or mild cognitive impairment caused by metabolic diseases cannot participate in this clinical trial.
- •A person who has the following clinical information recorded.
- •Date of birth (or full age), gender, APOE genotype, mild cognitive impairment diagnosis date, mild cognitive impairment causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe, cerebral tumor, cerebral infarction, normal pressure head disease, encephalitis, unknown, other), MRI scan day, amyloid PET test*, FBB PET-BAPL score** **However, for FBB PET BAPL score, you may participate in this clinical trial even if the information is not recorded.
排除标准
- •Brain MR images of image providers that fall under any of the following exclusion criteria cannot be registered in this clinical trial.
- •MR images already used as training sets or validation sets for developing medical devices for clinical trials.
- •☞Chonnam National University Hospital and Chosun University Hospital use images not included in GARD cohort.
- •If the interval between the date of diagnosis of mild cognitive impairment and the date of MRI scan/amyloid PET examination exceeds 2 years.
- •If the tester determines that participation in the clinical trial is inappropriate because it may affect other, ethical or clinical trial results.
- •Specific reasons shall be stated in the case record.
结局指标
主要结局
Explore predictive values(Clinical Specificity, %)
时间窗: Jun-2022 until Dec-2022
Clinical efficacy evaluation of the probability that 'NeuroAI' does not predict positive amyloid PET phase for MR images of negative factors as a result of amyloid PET test
Explore predictive values(Clinical Sensitivity, %)
时间窗: Jun-2022 until Dec-2022
Clinical efficacy evaluation of the probability of predicting 'NeuroAI' as positive amyloid PET phase for MR images of positive factors as a result of amyloid PET test
次要结局
- Explore predictive values(AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve))(Jun-2022 until Dec-2022)
- Explore predictive values(Accuracy, %)(Jun-2022 until Dec-2022)
研究者
研究点 (1)
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