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The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.
For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFDM Plus DBT | Experimental | Breast Images with FFDM and DBT |
|
| Full-Field Digital Mammography | Active Comparator | Breast Images with FFDM alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFDM Plus DBT | Device | FujiFilm Aspire Cristalle System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate | This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization. | The magnitude and direction of differences between performance metrics for the two modalities, and variance components and correlations that would influence sample size and case mix for the pivotal reader study (FMSU2013-004G) comparing performance metrics between the two modalities, obtained using established methods for analysis of MRMC (multi-reader, multi-case) studies. The statistician estimated AUC's for each reader in each review condition based on per-subject POM scores requiring correct lesion localization. Statistician performed MRMC comparison of AUC's between reading conditions using the MRMC analysis of variance (ANOVA) method. |
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Inclusion Criteria:
Exclusion Criteria:
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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, Limited (SMIL) | Scottsdale | Arizona | 85258 | United States | ||
| University of Iowa Hospitals and Clinics |
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Each radiologist read all 100 cases as FFDM only and FFDM+DBT(100 cases multiplied by 2 modalities = 200 reads) with a 4 week washout period between the 2 sessions.
The 100 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 Plus DBT, Then FFDM Only | Readers to read half of the FFDM plus DBT images followed by half of the FFDM only images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions. |
| FG001 | FFDM Only, Then FFDM Plus DBT | Readers to read half of the FFDM only images followed by half of the FFDM plus DBT images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Reading Session |
| |||||||||||||
| 4 Week Memory Washout Period |
| |||||||||||||
| Second Reading Session |
|
There were 100 study participants (resulting in 200 images) in total who had their images reviewed by 6 radiologist readers. Images were acquired under acquisition study FMSU2013-004A.
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| ID | Title | Description |
|---|---|---|
| BG000 | All 100 Cases/Study Participants | Each case contributed 2 sets of images: FFDM only as well as DBT plus FFDM. Therefore there were 200 reads acquired from the 100 cases/participants. |
| 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 | Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate | This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses. | The study employed a fully factorial, counterbalanced crossover design in which all readers reviewed images from all cases in two visits separated by a memory washout period of approximately 4 weeks. Each reader read half FFDM cases and half FFDM + DBT cases during each of 2 visits. | Posted | Mean | 95% Confidence Interval | probability | 4 weeks |
|
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 | Breast Images with FFDM and DBT FFDM Plus DBT: 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 |
| Device |
FujiFilm Aspire Cristalle System |
|
| 5 weeks |
| 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 |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FFDM Plus DBT |
Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System. This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate). |
| OG001 | Full-Field Digital Mammography (FFDM) | Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System. This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate). |
|
|
| Secondary | Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization. | The magnitude and direction of differences between performance metrics for the two modalities, and variance components and correlations that would influence sample size and case mix for the pivotal reader study (FMSU2013-004G) comparing performance metrics between the two modalities, obtained using established methods for analysis of MRMC (multi-reader, multi-case) studies. The statistician estimated AUC's for each reader in each review condition based on per-subject POM scores requiring correct lesion localization. Statistician performed MRMC comparison of AUC's between reading conditions using the MRMC analysis of variance (ANOVA) method. | Posted | Mean | 95% Confidence Interval | Probability | 5 weeks |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Full-Field Digital Mammography | Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System | 0 | 100 | 0 | 100 | 0 | 100 |
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| D017437 |
| Skin and Connective Tissue Diseases |