Diagnostic Performance of Hybrid PET/MRI in the Staging of Endometrial Carcinoma

Suspended

• Conditions: Endometrial Carcinoma

• Registration Number: NCT03945786
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Study Start: 2019-06-03
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-12-06
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic value of the distant metastasis	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Detection of endometrial carcinoma by hybrid PET/MRI	one month	In EC suspicious cases, sensitivity, specificity, accuracy, and positive and negative predictive values of hybrid PET/MRI for EC will be calculated, adopting D\&C pathological results as the gold standard.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China