Acquisition of Breast Mammography Images

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02156258
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Primary Completion: 2016-01
• Study Completion: 2017-01
• Results First Submitted: 2020-03-27
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Results First Posted: 2020-05-20
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1232

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants for Whom Study Image Data Were Collected	20 Months	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.

Trial Locations

Locations (5)

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