Breast Cancer
Conditions
Keywords
Mammography
Brief summary
The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.
Detailed description
The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.
Interventions
DEVICEFFDM Plus DBT
FFDM + DBT Images FujiFilm Aspire Cristalle System
DEVICEFFDM Alone
FFDM Alone Images
Sponsors
Fujifilm Medical Systems USA, Inc.
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites. * Meet none of the
Exclusion criteria
under protocol FMSU2013-004A.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization. | 1 month | The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result. |
Countries
United States
Participant flow
Recruitment details
The 298 breast screening and diagnostic cases selected for this study, were obtained from the FMSU2013-004A acquisition study. The statistician randomly selected cases to provide a distribution of density, finding types, etc.
Pre-assignment details
Reading radiologists independently read all 298 cases sequentially; first as an FFDM read, then as a FFDM + DBT read on the Aspire Bellus workstation. There was no washout, and all data below is entered correctly.
Participants by arm
| Arm | Count |
|---|---|
| All 298 Cases/Study Participants There were 298 study participants in total who had their images reviewed by 28 radiologist readers. Images were acquired under acquisition study FMSU2013-004A. | 298 |
| Total | 298 |
Baseline characteristics
| Characteristic | All 298 Cases/Study Participants |
|---|---|
| Age, Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 269 Participants |
| Region of Enrollment United States | 298 participants |
| Sex: Female, Male Female | 298 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 298 | 0 / 298 |
| other Total, other adverse events | 0 / 298 | 0 / 298 |
| serious Total, serious adverse events | 0 / 298 | 0 / 298 |
Outcome results
Primary
Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization.
The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result.
Time frame: 1 month
Population: Twenty-eight qualified radiologists independently performed reads on all 298 cases. Each radiologist reader read each case sequentially, first as a FFDM read, and then FFDM + DBT read, all on the Aspire Bellus workstation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FFDM Plus DBT | Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization. | 0.837 Probability |
| Full Field Digital Mammography (FFDM) | Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization. | 0.784 Probability |