- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03945786
Diagnostic Performance of Hybrid PET/MRI in the Staging of Endometrial Carcinoma
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100053
- Xuanwu Hospital, Capital Medical University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diagnostic value in the depth of endometrial infiltration
Tidsramme: 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.
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one month
|
Diagnostic value of the lymph nodes metastasis
Tidsramme: 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.
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one month
|
Diagnostic value of the distant metastasis
Tidsramme: one month
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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.
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one month
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Detection of endometrial carcinoma by hybrid PET/MRI
Tidsramme: 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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one month
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 首发2018-2-2013
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