Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
18. april 2016 opdateret af: Woo Kyung Moon, Seoul National University Hospital
Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.
Studieoversigt
Detaljeret beskrivelse
- Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists.
- The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively.
- Reference standard: Biopsy or 1 year of follow-up examination.
- The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1241
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Busan, Korea, Republikken
- Dongnam Inst. of Radiological and Medical Sciences
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Jinju, Korea, Republikken
- Gyeongsang National University Hospital
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Seongnam-si, Korea, Republikken
- CHA Bundang Medical Center, School of Medicine, CHA University
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Seoul, Korea, Republikken
- Seoul National University Hospital
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Seoul, Korea, Republikken
- Ewha Womans University Mokdong Hospital
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Seoul, Korea, Republikken
- Hanyang University Medical Center
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Seoul, Korea, Republikken
- Gangnam Severance Hospital, Yonsei University College of Medicine
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Seoul, Korea, Republikken
- Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
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Seoul, Korea, Republikken
- Seoul Metroplitan Government-Seoul National University Boramae Medical Center
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Seoul, Korea, Republikken
- Seoul National University Hospital Healthcare System Gangnam Center
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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
30 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Population will consist of asymptomatic women who visit the hospital for breast screening.
The sites are located in 4 cities of South Korea.
Beskrivelse
Inclusion Criteria:
- Women aged 30 years or older screened with breast ultrasound without specific symptoms
- Women who underwent mammography within 3 months which showed no abnormality except for dense breast
- Women who had at least one breast mass of BI-RADS category 3 or higher.
Exclusion Criteria:
- Women with breast implants
- Women who are unwilling or unable to provide informed consent
- Lesions larger than 3 cm
- Lesions that are previously noted and followed-up in the same hospital
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Breast masses detected with screening US
Those assessed with conventional B-mode US alone and those assessed with combined elastography and color doppler ultrasonography along with B-mode US.
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Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Positive predictive value of breast screening with US
Tidsramme: 1 year after enrollment
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Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
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1 year after enrollment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sensitivity
Tidsramme: 1 year after enrollment
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Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
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1 year after enrollment
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Specificity
Tidsramme: 1 year after enrollment
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Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
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1 year after enrollment
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Diagnostic accuracy
Tidsramme: 1 year after enrollment
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Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
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1 year after enrollment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Woo Kyung Moon, M.D., Ph.D., Seoul National University Hospital
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. november 2013
Primær færdiggørelse (Faktiske)
1. januar 2016
Studieafslutning (Faktiske)
1. januar 2016
Datoer for studieregistrering
Først indsendt
13. oktober 2013
Først indsendt, der opfyldte QC-kriterier
15. oktober 2013
Først opslået (Skøn)
16. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Elasto-Doppler Ultrasonography
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .