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出境医 / 临床实验 / Diagnostic Performance of Hybrid PET/MRI in the Staging of Endometrial Carcinoma

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

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

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
Layout table for study information
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 3, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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
Layout table for eligibility information
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

Locations
Layout table for location information
China, Beijing
Xuanwu Hospital, Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Tracking Information
First Submitted Date May 9, 2019
First Posted Date May 10, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date June 3, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: May 9, 2019) 		Diagnostic value in the depth of endometrial infiltration, lymphnodes number, metastasis whether of not in endometrial cancer by PET/MRI [ Time Frame: one month ]
In EC identified cases, sensitivity, specificity, accuracy, and positive and negative predictive values will be calculated for both regular staging method and hybrid PET/MRI method, adopting D&C pathological results as the gold standard. A receiver operating characteristic (ROC) curve was used to evaluate the diagnostic value between hybrid PET/MRI and regular method.
Change History
Current Secondary Outcome Measures
 (submitted: May 16, 2019) 		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.
Original Secondary Outcome Measures
 (submitted: May 9, 2019) 		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 will be calculated for hybrid PET/MRI, adopting D&C pathological results as the gold standard.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Endometrial Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Stecco A, Buemi F, Cassarà A, Matheoud R, Sacchetti GM, Arnulfo A, Brambilla M, Carriero A. Comparison of retrospective PET and MRI-DWI (PET/MRI-DWI) image fusion with PET/CT and MRI-DWI in detection of cervical and endometrial cancer lymph node metastases. Radiol Med. 2016 Jul;121(7):537-45. doi: 10.1007/s11547-016-0626-5. Epub 2016 Mar 31.
  • Kitajima K, Suenaga Y, Ueno Y, Kanda T, Maeda T, Takahashi S, Ebina Y, Miyahara Y, Yamada H, Sugimura K. Value of fusion of PET and MRI for staging of endometrial cancer: comparison with ¹⁸F-FDG contrast-enhanced PET/CT and dynamic contrast-enhanced pelvic MRI. Eur J Radiol. 2013 Oct;82(10):1672-6. doi: 10.1016/j.ejrad.2013.05.005. Epub 2013 May 30.
  • Nakajo K, Tatsumi M, Inoue A, Isohashi K, Higuchi I, Kato H, Imaizumi M, Enomoto T, Shimosegawa E, Kimura T, Hatazawa J. Diagnostic performance of fluorodeoxyglucose positron emission tomography/magnetic resonance imaging fusion images of gynecological malignant tumors: comparison with positron emission tomography/computed tomography. Jpn J Radiol. 2010 Feb;28(2):95-100. doi: 10.1007/s11604-009-0387-3. Epub 2010 Feb 26.
  • Li X, Zheng S, Chen S, Qin F, Lau S, Chen Q. Trends in gynaecological cancers in the largest obstetrics and gynaecology hospital in China from 2003 to 2013. Tumour Biol. 2015 Jul;36(7):4961-6. doi: 10.1007/s13277-015-3143-6. Epub 2015 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 9, 2019) 		120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03945786
Other Study ID Numbers 首发2018-2-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Wang Shijun, Xuanwu Hospital, Beijing
Study Sponsor Xuanwu Hospital, Beijing
Collaborators Not Provided
Investigators Not Provided
PRS Account Xuanwu Hospital, Beijing
Verification Date June 2019

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