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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBT plus S-View | Breast images utilizing DBT plus S-View |
| |
| FFDM alone | FFDM alone images |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBT plus S-View | Device | DBT plus S-View images |
| |
| FFDM Alone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a reader study utilizing retrospectively collected breast images acquired under Fujifilm protocol FMSU2013-004A.
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Uzenoff | Fujifilm Medical Systems USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International HealthCare, LLC | Norwalk | Connecticut | 06851 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | DBT Plus S-View, Then FFDM Only | Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions. |
| FG001 | FFDM Only, Then DBT Plus S-View | Readers will read half of the FFDM images followed by half of the DBT plus S-Viewonly images at each of 2 sessions. There was a four week memory washout period between the 2 sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Reading Session |
| |||||||||||||
| 4 Week Memory Washout Period |
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| Second Reading Session |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Error | Probability | 4 weeks |
approximately 5 weeks
There were no AE's expected for this study, as it was a radiologist reader study utilizing retrospective imaging. No study subjects were on-site for this retrospective review. No Adverse Events to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DBT Plus S-View | Breast images utilizing DBT plus S-View DBT plus S-View: DBT plus S-View images |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Vader | Fujifilm Medical Systems USA, Inc. | 360-356-6821 | randy.vader@fujifilm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2018 | Apr 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 5, 2018 | Apr 17, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Device |
FFDM alone images |
|
| 4 weeks |
| 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. | 4 weeks |
| 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. | Four weeks |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | DBT Plus S-View | Breast images utilizing DBT plus S-View DBT plus S-View: DBT plus S-View images |
| OG001 | FFDM Alone | FFDM alone images FFDM Alone: FFDM alone images |
|
|
| 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. | 240 non-cancer cases evaluated out of 300 total cases acquired under Fujifilm protocol FMSU2013-004A. | Posted | Mean | Standard Error | Proportion of cases correctly recalled | 4 weeks |
|
|
|
| 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. | 60 cancer cases were read (out of the total of 300 cases) from the previously acquired Fujifilm FMSU2013-004A acquisition study. | Posted | Mean | Standard Error | Proportion of cases correctly recalled | 4 weeks |
|
|
|
| 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. | Sensitivity was analyzed in 60 cancer cases. | Posted | Mean | Standard Error | Probability | Four weeks |
|
|
|
| 0 |
| 300 |
| 0 |
| 300 |
| 0 |
| 300 |
| EG001 | FFDM Alone | FFDM alone images FFDM Alone: FFDM alone images | 0 | 300 | 0 | 300 | 0 | 300 |
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| D017437 |
| Skin and Connective Tissue Diseases |