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

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ClinicalTrials.gov Identifier: NCT03945786
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Shijun, 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.

Condition or disease
Endometrial Carcinoma

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.


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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
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945786


Contacts
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Contact: Shijun Wang, MD +861083198417 dongpeng@xwhosp.org
Contact: Peng Dong, PhD +8618601041956 dongpeng@xwhosp.org

Locations
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China, Beijing
Xuanwu Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Xinya Wang, MD    +8683198853    sophiawangxinya@126.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing

Publications:
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Responsible Party: Wang Shijun, Director of Obstetrics and Gynecology Department, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03945786     History of Changes
Other Study ID Numbers: 首发2018-2-2013
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wang Shijun, Xuanwu Hospital, Beijing:
Hybrid PET/MRI

Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female