Diagnostic Performance of Simultaneous Hybrid (18)F-fluoro-D-glucose (FDG) Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) in the Preoperative Staging of Endometrial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic value of the distant metastasis
研究概览
简要总结
Endometrial carcinoma (EC) is one of the most common gynecologic malignancy in China. EC is staged surgically according to the International Federation of Gynecology and Obstetrics (FIGO) system, including depth of myometrial invasion, cervical invasion, and the presence of lymph node metastases. The benefit of lymph node resection on the prognosis of low-risk EC patients is not definite. An accurate staging method preoperative is needed.The purpose of this study is to evaluate the effect of simultaneous hybrid PET/MRI in EC preoperative staging.
详细描述
The treatment of EC is mainly surgery, mostly comprehensive staging surgery (complete hysterectomy, bilateral adnexectomy, pelvic and para-aortic lymph node resection). Lymph node metastasis rate in the early low-risk EC patients (histologically graded G1 and G2, myometrium invasion depth <50%, primary tumor diameter <2 cm) is low (<4%). Lymph node resection has no clear benefit on the prognosis of low-risk EC patients, but will bring greater trauma to the patients.
Accurate preoperative assessment of EC staging plays a decisive role in the individualized surgical range for EC patients. Preoperative imaging can assist in optimal treatment planning. Through ultrasound, MRI, PET we always cannot accurately measure the depth of muscle infiltration, lymph node metastasis and extra-uterine lesions. The simultaneous hybrid PET/MRI technology combines the characteristics of MRI in high-resolution imaging of soft tissue and the advantages of PET in strong ability to identify tumor metastases, so it may be capable for more accurate staging.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •EC suspicious patients consent to diagnostic curettage
- •Patients who pass standard clinical PET/MRI screening procedures
- •Undergoing surgical staging and/or debulking at Xuanwu Hospital, Beijing
排除标准
- •Allergy to (18)F-fluoro-D-glucose
- •Contraindication to MRI scanning
- •Pregnant or breast feeding patients
- •Participation in any other clinical trial which may interfere with this study
结局指标
主要结局
Diagnostic value of the distant metastasis
时间窗: one month
In EC identified cases, sensitivity, specificity, accuracy, and positive and negative predictive values will be calculated for distant metastasis detected by regular staging method and hybrid PET/MRI method, adopting D\&C pathological results as the gold standard.
Diagnostic value in the depth of endometrial infiltration
时间窗: one month
In EC identified cases, sensitivity, specificity, accuracy, and positive and negative predictive values will be calculated for depth of endometrial infiltration measured by regular staging method and hybrid PET/MRI method, adopting D\&C pathological results as the gold standard.
Diagnostic value of the lymph nodes metastasis
时间窗: one month
In EC identified cases, sensitivity, specificity, accuracy, and positive and negative predictive values will be calculated for lymph nodes metastasis detected by regular staging method and hybrid PET/MRI method, adopting D\&C pathological results as the gold standard.
次要结局
- Detection of endometrial carcinoma by hybrid PET/MRI(one month)
研究者
Wang Shijun
Director of Obstetrics and Gynecology Department
Xuanwu Hospital, Beijing