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Endometrial CarcinomaNCT03945786

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

An observational study of Endometrial Carcinoma, run by Xuanwu Hospital, Beijing at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Carcinoma
How many people
120 participants
Where
1 siteChina
Study dates
3 Jun 2019to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women with irregular vaginal bleeding, abnormal vaginal discharge and/or other risk factors for EC undergoing diagnostic curettage.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

Other trials in China

About this study

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

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.

Read the 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.

Keywords
Hybrid PET/MRI
Medical subject headings
Endometrial Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: one month

  2. 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.

    Measured: one month

  3. 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.

    Measured: one month

Secondary outcomes (1)

  1. Detection of endometrial carcinoma by hybrid PET/MRI

    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.

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start3 Jun 2019
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Why it stopped: Recuriting inclusion and exclusion criteria will be changed as COVID-19.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03945786
Sponsor's protocol ID
首发2018-2-2013
Status last verified
Nov 2021
First submitted
9 May 2019
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27033474

  • 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.

    PubMed 23727380

  • 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.

    PubMed 20182843

  • 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.

    PubMed 25649977

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Carcinoma, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic value in the depth of endometrial infiltration (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945786, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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