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| Name | Class |
|---|---|
| International HealthCare, LLC | OTHER |
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The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).
This clinical research is a retrospective, feature comparison reader study with an enriched sample of 600 (100 per radiologist) 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).
Six MQSA-qualified and board-certified mammographers representing various experience levels, will be shown DBT images of a breast with the modified processing side-by-side the same breast with the original processing on the ASPIRE Bellus II workstation.. One breast per subject (two views per breast; CC and MLO) will be evaluated by the readers. Readers will be blinded to the image reconstruction and presentation processing methods. Each reader will be given a different sample of cases to review. Approximately 600 total cases (100 cases per reader) will compose the sample. The order of the subjects and location (left or right review workstation high resolution monitor) of the images with modified processing will be randomized for each reader.
The primary objective is the readers' assessment for each of the 7 general mammographic features. The null hypothesis is that the pooled proportion of cases judged as non-inferior with modified image processing is <0.50, versus the alternative hypothesis that the pooled proportion is >0.50. If the 95% CI does not contain values <0.50, then the null hypothesis will be rejected. These hypotheses will be evaluated for each of the 7 general mammographic features. If all 7 null hypotheses are rejected, then it will be concluded that the modified imaging features are non-inferior to the original imaging
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FBP (old processing) | Filtered back projection; old processing. |
| |
| ISR (new processing) | Iterative super resolution; new processing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FBP | Device | Old processing |
| |
| ISR |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of ISR (Modified Processing) to FBP (Original Processing) | For each reader, the cases judged as non-inferior with modified processing will be calculated for each feature and each view. Non-inferiority will be defined as a score of equivalence between modified and original or a score indicating the modified image processing is superior. Readers compared several general mammographic features using the following 5-point scale: negative 2 (left image much superior) negative 1 (left image somewhat superior) 0 (left and right images are equivalent) positive 1 (right image somewhat superior) positive 2 (right image much superior) | 1 day reading session |
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Inclusion Criteria:
Exclusion Criteria:
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600
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| Name | Affiliation | Role |
|---|---|---|
| Susan Crennan | 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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6 qualified radiologists were shown DBT (Tomosynthesis) of a breast with the modified processing side-by-side the same breast with the original processing. Each reader was given a unique sample of 100 cases to review. Images were acquired under Fujifilm image acquisition protocol FMSU2013-004A
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| ID | Title | Description |
|---|---|---|
| FG000 | FBP (Old Processing) and ISR (New Processing) | Radiologists reviewed images of a breast with ISR side-by-side the same breast with FBP. They were blinded to the image reconstruction and presentation processing methods. Radiologists compared several general mammographic features and were asked to grade each feature on each view using the 5-point Likert scale outlined previously. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FBP (Old Processing)/ISR (New Processing) | Filtered back projection (old processing) and ISR (new processing) images of the same breast are presented side-by-side for radiologist review. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Comparison of ISR (Modified Processing) to FBP (Original Processing) | For each reader, the cases judged as non-inferior with modified processing will be calculated for each feature and each view. Non-inferiority will be defined as a score of equivalence between modified and original or a score indicating the modified image processing is superior. Readers compared several general mammographic features using the following 5-point scale: negative 2 (left image much superior) negative 1 (left image somewhat superior) 0 (left and right images are equivalent) positive 1 (right image somewhat superior) positive 2 (right image much superior) | Six readers read a cohort of images acquired under a prior acquisition study protocol (FMSU2013-004A). Statistician provided results for ISR (modified/new processing only) that was already analyzed/compared to FBP (old processing). | Posted | Mean | 95% Confidence Interval | 5-point scale | 1 day reading session |
|
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 | FBP (Old Processing) | This was a reader study where radiologists/readers compared processing of previously acquired 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 | May 15, 2018 | May 5, 2020 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2018 | May 5, 2020 | SAP_002.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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| Device |
New processing |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Iterative super resolution; new processing. ISR: New processing |
|
|
| 0 |
| 600 |
| 0 |
| 600 |
| 0 |
| 600 |
| EG001 | ISR (New Processing) | This was a reader study where radiologists/readers compared processing of previously acquired images. | 0 | 600 | 0 | 600 | 0 | 600 |
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| D017437 |
| Skin and Connective Tissue Diseases |