Breast Cancer
Conditions
Brief summary
The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.
Detailed description
This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of 300 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 18 qualified radiologists will independently perform two reads on all (approximately 300) cases. Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE Bellus II workstation. As its primary endpoint, this study is designed to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability of malignancy (POM) scores and requiring correct lesion localization is statistically non-inferior for DBT plus S-View versus FFDM.
Interventions
DEVICEDBT plus S-View
DBT plus S-View images
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
* •Female subjects participating in FMSU2013-004A protocol with known clinical status
Exclusion criteria
* •Female subjects that did not have known clinical status in FMSU2013-004A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare Per Subject AUC: DBT Plus S-View Versus FFDM | 4 weeks | Average of each radiologist reader's ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM | 4 weeks | Based on recall rate for all non-cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.05. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category. |
| Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases | 4 weeks | Based on recall rate for all cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category. |
| Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM | Four weeks | Based on forced BI-RADS scores requiring correct lesion localization, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category. |
Countries
United States
Participant flow
Pre-assignment details
This was a retrospective, multi-reader multi-case reader study. 18 radiologist readers read all 300 cases (half FFDM and half DBT plus S-View reads) at each of 2 visits which were separated by a memory washout period of approximately 4 weeks. Images were previously acquired under Fujifilm protocol FMSU2013-004A.
Participants by arm
| Arm | Count |
|---|---|
| DBT Plus S-View and FFDM Alone 300 retrospectively collected breast images to be reviewed (both DBT plus S-View and FFDM alone for all 300 images) | 300 |
| Total | 300 |
Baseline characteristics
| Characteristic | DBT Plus S-View and FFDM Alone |
|---|---|
| Age, Customized Particant Age Mean | 56.5 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 260 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 24 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 | 3 Participants |
| Race (NIH/OMB) White | 270 Participants |
| Region of Enrollment United States | 300 participants |
| Sex: Female, Male Female | 300 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 / 300 | 0 / 300 |
| other Total, other adverse events | 0 / 300 | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 | 0 / 300 |
Outcome results
Primary
Compare Per Subject AUC: DBT Plus S-View Versus FFDM
Average of each radiologist reader's ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject.
Time frame: 4 weeks
Population: Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 300 images in their own randomized order during 2 sessions (they read half of each modality at each session which were separated by a 4 week washout period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBT Plus S-View | Compare Per Subject AUC: DBT Plus S-View Versus FFDM | 0.794 Probability | Standard Error 0.032 |
| FFDM Alone | Compare Per Subject AUC: DBT Plus S-View Versus FFDM | 0.764 Probability | Standard Error 0.035 |
Secondary
Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM
Based on recall rate for all non-cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.05. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.
Time frame: 4 weeks
Population: 240 non-cancer cases evaluated out of 300 total cases acquired under Fujifilm protocol FMSU2013-004A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBT Plus S-View | Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM | 0.342 Proportion of cases correctly recalled | Standard Error 0.026 |
| FFDM Alone | Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM | 0.415 Proportion of cases correctly recalled | Standard Error 0.027 |
Secondary
Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases
Based on recall rate for all cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.
Time frame: 4 weeks
Population: 60 cancer cases were read (out of the total of 300 cases) from the previously acquired Fujifilm FMSU2013-004A acquisition study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBT Plus S-View | Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases | 0.679 Proportion of cases correctly recalled | Standard Error 0.048 |
| FFDM Alone | Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases | 0.643 Proportion of cases correctly recalled | Standard Error 0.049 |
Secondary
Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM
Based on forced BI-RADS scores requiring correct lesion localization, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is no the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of no. If the reader answers yes to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.
Time frame: Four weeks
Population: Sensitivity was analyzed in 60 cancer cases.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBT Plus S-View | Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM | 0.679 Probability | Standard Error 0.048 |
| FFDM Alone | Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM | 0.643 Probability | Standard Error 0.049 |