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Xpress Digital Mammography System Images for Computer Aided Detection Development

3. december 2012 opdateret af: Konica Minolta Medical Imaging, USA

A Multi-Center Clinical Study to Acquire Xpress Digital Mammography System Images for Computer Aided Detection Development

The primary objective of this study is to acquire digital mammography images produced by the Xpress Digital Mammography System in order to develop Computer Aided Detection software and systems.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The proposed study is an image acquisition study of mammograms produced by the investigational digital system. Women who meet the selection criteria and who agree to participate in the study will be imaged with the Xpress Digital Mammography System at the clinical sites. These images will be provided to CAD development companies to conduct their own development and testing. The CAD development companies will be responsible for submitting their results to the FDA for marketing approval of their CAD systems.

Patients will be drawn primarily from those women scheduled for breast biopsy since this population has an enhanced probability of cancer. The intent is to enroll patients until at least 107 women with biopsy proven cancers, and at least 330 women who have negative mammograms are enrolled. All cancers found will be used in the study. It is anticipated that approximately 720 patients undergoing diagnostic mammography will need to be enrolled to yield 107 proven cancer cases. In addition, approximately 330 cases will be drawn from a screening population. The negative status of the screening cases will be established by selecting only cases classified as BIRADS 1 or 2, and have a negative mammogram at one year follow-up. All images collected will be utilized to develop and test the CAD systems, and may be used for further product development.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

597

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater
        • Waterbury Hospital
    • Florida
      • Miami, Florida, Forenede Stater
        • Jackson Memorial Hospital
    • Iowa
      • Iowa City, Iowa, Forenede Stater
        • University of Iowa
    • South Carolina
      • Greenville, South Carolina, Forenede Stater
        • Greenville Hospital Systems
    • Texas
      • San Antonio, Texas, Forenede Stater
        • University of Texas San Antonio

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

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

To achieve the goal of 107 cases with biopsy-proven cancer, it is expected that approximatley 720 patients undergoing breast biopsy will need to be enrolled in the study. In addition, we will enroll up to 330 patients from a screening population.

Beskrivelse

Inclusion Criteria

Cases selected for the study must meet all of the following criteria:

  • Female
  • Scheduled for a routine screening mammography or routine breast biopsy for non-palpable findings
  • Any ethnic origin

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

  • Any contraindication to mammography
  • Pregnant or suspicion of being pregnant, or nursing
  • Patients with palpable lesions
  • Patients with internal breast markers in the region of interest
  • Breast implants, without displaced views
  • Significant recent breast trauma/acute mastitis
  • Patient has previously undergone an excisional breast biopsy
  • Patients with a history of breast cancer
  • Unable or unwilling to give consent

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
Screening Patients
Female patients scheduled for routine annual screening mammograms
Biopsy Patients
Female patients scheduled for routine breast biopsy procedures

Samarbejdspartnere og efterforskere

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

Sponsor

Konica Minolta Medical Imaging, USA

Efterforskere

  • Ledende efterforsker: Etta Pisano, MD, Medical University of South Carolina

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. februar 2010

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

1. februar 2010

Først indsendt, der opfyldte QC-kriterier

1. februar 2010

Først opslået (Skøn)

2. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. december 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2012

Sidst verificeret

1. december 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • #03

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 .

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