- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01061138
Xpress Digital Mammography System Images for Computer Aided Detection Development
A Multi-Center Clinical Study to Acquire Xpress Digital Mammography System Images for Computer Aided Detection Development
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Connecticut
-
Waterbury, Connecticut, Förenta staterna
- Waterbury Hospital
-
-
Florida
-
Miami, Florida, Förenta staterna
- Jackson Memorial Hospital
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna
- University of Iowa
-
-
South Carolina
-
Greenville, South Carolina, Förenta staterna
- Greenville Hospital Systems
-
-
Texas
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San Antonio, Texas, Förenta staterna
- University of Texas San Antonio
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Screening Patients
Female patients scheduled for routine annual screening mammograms
|
Biopsy Patients
Female patients scheduled for routine breast biopsy procedures
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Etta Pisano, MD, Medical University of South Carolina
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- #03
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