A Fast, Quiet, Artificial Intelligence-based PET/MR Solution for Paediatric Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Lesion detection rate
研究概览
简要总结
To investigate the feasibility of deep learning-assisted rapid silent PET/MR in pediatric applications.
详细描述
This study aims to address the challenges faced by PET/MR in pediatric applications by leveraging new technologies such as flexible coils, silent sequences, and deep learning-based image reconstruction. The objective is to provide a rapid, silent, comfortable, and half-dose PET/MR imaging solution for pediatric patients, and to demonstrate its feasibility in this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have clinical symptoms and are suspected of having malignant tumors after being evaluated by clinical pediatricians and require 18F-FDG PET/MR examination to further clarify their conditions.
- •Signed and dated informed consent form
- •Commit to complying with the research procedures and cooperate in the implementation of the entire research process.
- •No gender restriction, aged between 0 and 18 years old.
排除标准
- •Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- •Patients with severe claustrophobia，epileptic seizures, respiratory distress who cannot lie down, and patients with mental anomalies who are unable to cooperate.
- •Patients with metal implants such as pacemakers, artificial metal heart valves, and neurostimulators in their bodies.
- •Non-compliant person.
结局指标
主要结局
Lesion detection rate
时间窗: 1 year
Routine laboratory or imaging tests or pathology are performed based on clinical needs to assess the accuracy, sensitivity and specificity of rapid silent 18F-FDG PET/MR for lesion detection.
Completion of PET/MR examinations
时间窗: 1 year
Upon completion of the examination, record the rate of completion
Sedation during PET/MR examinations
时间窗: 1 year
Upon completion of the examination, record the rate of sedation and rate of secondary sedation
Qualitative image quality
时间窗: 1 year
Two experienced nuclear medicine physicians evaluated the overall quality of the images using a Likert 5-point scale for both the new imaging PET/MR protocol and the traditional imaging protocol.
次要结局
未报告次要终点