Acquisition of Breast Mammography Images

Study Overview
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Brief Summary
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This is a case collection study of breast images using standard and new mammography technology.

Detailed Description
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This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.

Official Title
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Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: FFDM Mammography
* Device: DBT Mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Screening Subjects Be at least 40 years of age, are Asymptomatic, Scheduled for a routine screening mammogram For Recall Subjects Be at least 18 years of age, Received a BIRADS 0 within the last 60 days Are recalled for additional imaging For Diagnostic Subjects Be at least 18 years of age, Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days. Understand requirements and willing to participate in study Exclusion Criteria: Presence of a breast implant. Women with only a single breast; for example, post mastectomy patients. Is pregnant or believes she may be pregnant. A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding. A woman who has significant existing breast trauma within the last one year. Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations. A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year. Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution. Is an inmate (see US Code of Federal Regulations 45CFR46.306).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic Cases<br>Collection of cases that were scheduled for biopsy (BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography | Device: FFDM Mammography<br>* Standard mammography image collection<br>Device: DBT Mammography<br>* Collection of breast images using DBT mammography<br>|
| Recall Cases<br>Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography | Device: FFDM Mammography<br>* Standard mammography image collection<br>Device: DBT Mammography<br>* Collection of breast images using DBT mammography<br>|
| Screening Cases<br>Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography | Device: FFDM Mammography<br>* Standard mammography image collection<br>Device: DBT Mammography<br>* Collection of breast images using DBT mammography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Whom Study Image Data Were Collected | This study created a library of image data to be used in future projects, future product development and regulatory submissions. There was no analysis conducted aside from confirmation of complete images and collected data , as this was merely a collection of images to be used in future reader studies. Sites were provided a target distribution of diagnostic, recall and screening cases to obtain. | 20 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging, Mammography