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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03945786

Recruitment Status Enrolling by invitation

First Posted May 10, 2019

Last update posted June 6, 2019

Study Description

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.

  • Condition or Disease:Endometrial Carcinoma
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Estimated Enrollment: 120 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2021
Outcome Measures
  • Primary Outcome Measures: 1. Diagnostic value in the depth of endometrial infiltration [ Time Frame: 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.
  • 2. Diagnostic value of the lymph nodes metastasis [ Time Frame: 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.
  • 3. Diagnostic value of the distant metastasis [ Time Frame: 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.
  • Secondary Outcome Measures: 1. Detection of endometrial carcinoma by hybrid PET/MRI [ Time Frame: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
  • 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.
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

Contacts and Locations
Contacts
Locations

China, Beijing
Xuanwu Hospital, Capital Medical University
Beijing

Sponsors and Collaborators

Xuanwu Hospital, Beijing

More Information