Clinical Model-Based Evaluation of High-Penetration Super-Resolution Transcranial Ultrasound for Early Diagnosis of Intracranial Metallic Foreign Bodies in Patients After Intracranial Aneurysm Clipping
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 主要终点
- Patient-level sensitivity for identifying the presence or absence of intracranial metallic targets
研究概览
简要总结
To evaluate the patient-level early diagnostic performance of high-penetration super-resolution transcranial ultrasound for identifying intracranial metallic targets, and to further assess clip-level detection, localization, agreement, and its complementary value to routine postoperative imaging.This study does not alter routine clinical treatment. All participants will undergo standardized high-penetration super-resolution transcranial ultrasound within 3 hours after surgery. Postoperative CT is mandatory for all participants; CTA or other routine postoperative imaging will be obtained only when clinically indicated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years;
- •Positive group: patients undergoing intracranial aneurysm clipping with implanted metallic clips; negative control group: postoperative craniotomy patients without implanted clips;
- •Ability to complete transcranial ultrasound within 3 hours after surgery;
- •Availability of postoperative CT;
- •Written informed consent from the participant or legally authorized representative.
排除标准
- •Inability to complete standardized transcranial ultrasound;
- •Missing postoperative CT;
- •Inability to establish the composite reference standard;
- •Presence of non-study-related metallic materials that may substantially interfere with target identification;
- •Withdrawal of consent;
- •Investigator judgment that continued participation is inappropriate.
研究组 & 干预措施
Positive group
Metallic-clip model group
Negative control group
Negative postoperative control group
结局指标
主要结局
Patient-level sensitivity for identifying the presence or absence of intracranial metallic targets
时间窗: Within 24 hours after surgery upon completion of composite reference standard adjudication
Patient-level specificity for identifying the presence or absence of intracranial metallic targets
时间窗: Within 24 hours after surgery upon completion of composite reference standard adjudication
次要结局
未报告次要终点
研究者
Cong Feng
Professor
Chinese PLA General Hospital