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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Connecticut
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Waterbury, Connecticut, États-Unis
- Waterbury Hospital
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Florida
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Miami, Florida, États-Unis
- Jackson Memorial Hospital
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Iowa
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Iowa City, Iowa, États-Unis
- University of Iowa
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South Carolina
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Greenville, South Carolina, États-Unis
- Greenville Hospital Systems
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Texas
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San Antonio, Texas, États-Unis
- University of Texas San Antonio
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Screening Patients
Female patients scheduled for routine annual screening mammograms
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Biopsy Patients
Female patients scheduled for routine breast biopsy procedures
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Etta Pisano, MD, Medical University of South Carolina
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- #03
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