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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFDM Plus DBT | FFDM Plus DBT images are being evaluated as compared to FFDM alone |
| |
| Full Field Digital Mammography | Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFDM Plus DBT | Device | FFDM + DBT Images FujiFilm Aspire Cristalle System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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This research is a retrospective study with an enriched sample of breast screening or diagnostic cases that were selected from the library of mammograms collected 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 |
|---|---|---|---|---|---|---|
| Scottsdale Medical Imaging, Ltd | Scottsdale | Arizona | 85258 | United States | ||
| University of Iowa Hospitals and Clinics |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | FFDM Alone Then FFDM Plus DBT | FFDM images are being evaluated as compared to FFDM Plus DBT FujiFilm Aspire Cristalle System This is a sequential read, each reader read the case as a FFDM read followed by a FFDM plus DBT read |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 298 study participants in total who had their images reviewed by 28 radiologist readers. Images were acquired under acquisition study FMSU2013-004A.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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. | 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. | Posted | Mean | 95% Confidence Interval | Probability | 1 month |
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 | FFDM Plus DBT | FFDM Plus DBT images are being evaluated as compared to FFDM alone FFDM Plus DBT: FFDM + DBT Images FujiFilm Aspire Cristalle System |
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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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| 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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| FFDM Alone |
| Device |
FFDM Alone Images |
|
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Elizabeth Wende Breast Care, LLC (EWBC) | Rochester | New York | 14620 | United States |
| University of North Carolina - at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | FFDM Plus DBT | FFDM Plus DBT images are being evaluated as compared to FFDM alone FFDM Plus DBT: FFDM + DBT Images FujiFilm Aspire Cristalle System |
| OG001 | Full Field Digital Mammography (FFDM) | Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT FFDM Alone: FFDM Alone Images |
|
|
| 0 |
| 298 |
| 0 |
| 298 |
| 0 |
| 298 |
| EG001 | Full Field Digital Mammography | Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT FFDM Alone: FFDM Alone Images | 0 | 298 | 0 | 298 | 0 | 298 |
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| D017437 |
| Skin and Connective Tissue Diseases |