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

NCT03945786 | Suspended DMC

• 1 other identifier: 首发2018-2-2013
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Carcinoma

Keywords

Hybrid PET/MRI

Outcome Measures

Primary Outcomes (3)

• Diagnostic value in the depth of endometrial infiltration

  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.

  one month

• Diagnostic value of the lymph nodes metastasis

  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.

  one month

• Diagnostic value of the distant metastasis

  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.

  one month

Secondary Outcomes (1)

• Detection of endometrial carcinoma by hybrid PET/MRI

  one month

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (4)

• Stecco A, Buemi F, Cassara 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.

  PMID: 27033474 BACKGROUND

• 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 (1)(8)F-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.

  PMID: 23727380 BACKGROUND

• 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.

  PMID: 20182843 BACKGROUND

• 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.

  PMID: 25649977 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetrics and Gynecology Department

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: June 3, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

CN (1)