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The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 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 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBT plus S-View | Breast images utilizing DBT plus S-View |
| |
| FFDM alone | Breast images using FFDM alone only |
|
| 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 Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC) | Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al. | 2 visits with 4 week washout period |
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Inclusion Criteria:
Exclusion Criteria:
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This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 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).
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| Name | Affiliation | Role |
|---|---|---|
| Laurie L. Fajardo, M.D. | independent contractor | Principal Investigator |
| 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. Six (6) radiologist readers read all 100 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 | 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 Alone | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Reading Session |
| |||||||||||||
| 4 Week Memory Washout Period |
| |||||||||||||
| Second Reading Session |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DBT Plus S-View and FFDM Alone | 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. |
| 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 | Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC) | Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al. | Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 100 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 | 95% Confidence Interval | Probability | 2 visits with 4 week washout period |
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 | Oct 12, 2017 | May 12, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2017 | May 12, 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 |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | DBT Plus S-View | 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. |
| OG001 | FFDM Alone | 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. |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | FFDM Alone | Breast images using FFDM alone only FFDM alone: FFDM alone images | 0 | 100 | 0 | 100 | 0 | 100 |
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| D017437 |
| Skin and Connective Tissue Diseases |