Clinical trial NCT03945786: Diagnostic Performance of Hybrid PET/MRI in the Staging of Endometrial Carcinoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Endometrial Carcinoma
Keywords: Hybrid PET/MRI
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with irregular vaginal bleeding, abnormal vaginal discharge and/or other risk factors for EC undergoing diagnostic curettage.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic value in the depth of endometrial infiltration
timeFrame: one month
measure: Diagnostic value of the lymph nodes metastasis
timeFrame: one month
measure: Diagnostic value of the distant metastasis
timeFrame: one month
Secondary outcomes:
measure: Detection of endometrial carcinoma by hybrid PET/MRI
timeFrame: one month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References:
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