Acquisition of Breast Mammography Images

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-01-31

Brief Summary

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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic Cases

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

FFDM Mammography

Intervention Type DEVICE

Standard mammography image collection

DBT Mammography

Intervention Type DEVICE

Collection of breast images using DBT mammography

Recall Cases

Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography

FFDM Mammography

Intervention Type DEVICE

Standard mammography image collection

DBT Mammography

Intervention Type DEVICE

Collection of breast images using DBT mammography

Screening Cases

Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography

FFDM Mammography

Intervention Type DEVICE

Standard mammography image collection

DBT Mammography

Intervention Type DEVICE

Collection of breast images using DBT mammography

Interventions

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FFDM Mammography

Standard mammography image collection

Intervention Type DEVICE

DBT Mammography

Collection of breast images using DBT mammography

Intervention Type DEVICE

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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes