N/A
N=1,232
Acquisition of Breast Mammography Images
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02156258 ↗Enrolled (actual)
1,232
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants for Whom Study Image Data Were Collected — 642; 124; 244 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- FFDM Mammography (Device); DBT Mammography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fujifilm Medical Systems USA, Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants for Whom Study Image Data Were Collected |
642; 124; 244 | — |
Summary
This is a case collection study of breast images using standard and new mammography technology.
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,
- 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).
Data sourced from ClinicalTrials.gov (NCT02156258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.