Acquisition of Breast Mammography Images

FujiFilm

Status: Completed

Conditions: Breast Cancer

Treatments: Device: DBT Mammography; Device: FFDM Mammography

Study type: Observational

Funder types: Industry

Identifiers

NCT02156258

FMSU2013-004A

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,232 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

1,232 participants in 3 patient groups

Diagnostic Cases

Description:

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

Treatment:

Device: DBT Mammography

Device: FFDM Mammography

Recall Cases

Description:

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

Treatment:

Device: DBT Mammography

Device: FFDM Mammography

Screening Cases

Description:

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

Treatment:

Device: DBT Mammography

Device: FFDM Mammography