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.