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ShearWave™ Elastography of Breast Lesions in Chinese Patients (BE3)

18. december 2018 opdateret af: SuperSonic Imagine

Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients

We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.

Studieoversigt

Status

Afsluttet

Betingelser

Brystneoplasmer

Detaljeret beskrivelse

Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2273

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Kina
- - Beijing, Kina
    - Beijing Friendship hospital, Capital Medical University
  - Beijing, Kina
    - 1st Affiliated Hospital of PLAGH (304)
  - Beijing, Kina
    - People's Liberation Army General Hospital (301)
  - Binzhou, Kina
    - Affiliated Hospital of Binzhou Medical University
  - Chengdu, Kina
    - West China Hospital, Sichuan University
  - Chengdu, Kina
    - Sichuan Provincial People's Hospital
  - Fuzhou, Kina
    - Fujian Provincial Cancer Hospital
  - Guangzhou, Kina
    - Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  - Guangzhou, Kina
    - Guangdong Provincial Traditional Chinese Medical Hospital
  - Guangzhou, Kina
    - Sun-Yat Sen University Cancer Center
  - Harbin, Kina
    - 1st Affiliated Hospital of Harbin University
  - Hefei, Kina
    - Hefei 2nd People's Hospital
  - Nanjing, Kina
    - Jiangsu Provincial Hospital
  - Ningbo, Kina
    - Yinzhou People's Hospital
  - Shanghai, Kina
    - Fudan University Cancer Center
  - Shenyang, Kina
    - Shengjing Hospital of China Medical University
  - Shenyang, Kina
    - 1st Affiliated Hospital of China Medical University
  - Shenyang, Kina
    - 4th Affiliated Hospital of China Medical University
  - Taiyuan, Kina
    - General Hospital of TISCO
  - Taiyuan, Kina
    - Shanxi Dayi Hospital
  - Xi'an, Kina
    - 1st Affiliated Hospital of Xi'an Jiaotong University
  - Zhengzhou, Kina
    - 1st Affiliated Hospital of Zhengzhou University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Chinese women (age of majority) who have been referred to a hospital or clinical for a breast ultrasound evaluation.

Beskrivelse

Inclusion Criteria:

female
18 years of age or older
known breast lesion that has not been managed or treated
referred for a breast ultrasound because of a breast mass found on at least one of the following examinations:
- physical palpation
- mammography
- ultrasound exam
- MRI

Exclusion Criteria:

Women who are unwilling or unable to provide informed consent
Women with breast implants
Women who are pregnant or breastfeeding
Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6
Women with previous ipsilateral breast surgery
Women with no visible breast mass on ultrasound examination
Women with axillary metastatic lymph nodes only
Women with foreign body in the breast
Women who are not Chinese nationality

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Increase in specificity of breast ultrasound imaging when considering stiffness measurements Tidsramme: Within 18 months of the study start date	Within 18 months of the study start date

Sekundære resultatmål

Resultatmål	Tidsramme
Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements Tidsramme: Within 18 months of the study start date	Within 18 months of the study start date
Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements Tidsramme: within 18 months of the study start date	within 18 months of the study start date

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SuperSonic Imagine

Efterforskere

Ledende efterforsker: Cai Chang, Fudan University
Ledende efterforsker: Anhua Li, Sun Yat-sen University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Lin X, Chang C, Wu C, Chen Q, Peng Y, Luo B, Tang L, Li J, Zheng J, Zhou R, Cui G, Li A, Wang X, Qian L, Zhang J, Wen C, Gay J, Zhang H, Li A, Chen Y. Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial. Cancer Manag Res. 2018 Oct 11;10:4447-4458. doi: 10.2147/CMAR.S174690. eCollection 2018.

Hjælpsomme links

Full-length article in Cancer Management and Research journal

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2014

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)