Clinical Trials Directory

Trials / Suspended

SuspendedNCT03945786

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

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

Status
Suspended
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Xuanwu Hospital, Beijing · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2019-06-03
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2019-05-10
Last updated
2021-12-06

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03945786. Inclusion in this directory is not an endorsement.