Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Fujifilm Medical Systems USA, Inc.
- Enrollment
- 1232
- Locations
- 5
- Primary Endpoint
- Number of Participants for Whom Study Image Data Were Collected
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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,
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).
Outcomes
Primary Outcomes
Number of Participants for Whom Study Image Data Were Collected
Time Frame: 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.