Breast Cancer
Conditions
Keywords
Imaging, Mammography
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.
Interventions
DEVICEFFDM Mammography
Standard mammography image collection
DEVICEDBT Mammography
Collection of breast images using DBT mammography
Sponsors
Fujifilm Medical Systems USA, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic Cases Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography
FFDM Mammography: Standard mammography image collection
DBT Mammography: Collection of breast images using DBT mammography | 674 |
| Recall Cases Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography
FFDM Mammography: Standard mammography image collection
DBT Mammography: Collection of breast images using DBT mammography | 203 |
| Screening Cases Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography
FFDM Mammography: Standard mammography image collection
DBT Mammography: Collection of breast images using DBT mammography | 355 |
| Total | 1,232 |
Baseline characteristics
| Characteristic | Diagnostic Cases | Recall Cases | Screening Cases | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 156 Participants | 39 Participants | 81 Participants | 276 Participants |
| Age, Categorical Between 18 and 65 years | 518 Participants | 164 Participants | 274 Participants | 956 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 100 Participants | 32 Participants | 26 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 564 Participants | 161 Participants | 316 Participants | 1041 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 13 Participants | 33 Participants |
| Region of Enrollment United States | 674 participants | 203 participants | 355 participants | 1232 participants |
| Sex: Female, Male Female | 674 Participants | 203 Participants | 355 Participants | 1232 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 674 | 0 / 203 | 0 / 355 |
| other Total, other adverse events | 1 / 674 | 0 / 203 | 0 / 355 |
| serious Total, serious adverse events | 0 / 674 | 0 / 203 | 0 / 355 |
Outcome results
Primary
Number of Participants for Whom Study Image Data Were Collected
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.
Time frame: 20 Months
Population: Difference between enrolled and analyzed are those that were discontinued due to not returning for 1 year follow-up, etc. All cases were reviewed to ensure complete images and data, that was the extent of the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic Cases | Number of Participants for Whom Study Image Data Were Collected | 642 Participants |
| Recall Cases | Number of Participants for Whom Study Image Data Were Collected | 124 Participants |
| Screening Cases | Number of Participants for Whom Study Image Data Were Collected | 244 Participants |