Acquisition of Breast Mammography Images

Completed

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT02156258

Run by

Fujifilm Medical Systems USA, Inc.

People needed

1232

Starts

2014-06-01

Expected to finish

2017-01-01

Last updated by the study team

2020-05-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Scottsdale Medical Imaging, Ltd — Scottsdale, Arizona, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Elizabeth Wende Breast Care, LLC — Rochester, New York, United States
• University of North Carolina - at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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