An observational study in Breast Cancer, sponsored by Fujifilm Medical Systems USA, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Fujifilm Medical Systems USA, Inc. · Observational
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
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 600 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fujifilm Medical Systems USA, Inc. is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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600
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Exclusion Criteria:
Filtered back projection; old processing.
Device: FBP
Iterative super resolution; new processing.
Device: ISR
Old processing
New processing
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)
Time frame: 1 day reading session
| Milestone | FBP (Old Processing) and ISR (New Processing) |
|---|---|
| Started | 600 |
| Completed | 600 |
| Not completed | 0 |
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)
| 5-point scale | ISR (New Processing) |
|---|---|
| MLO | 0.83 (0.66 to 0.95) |
| Uniformity | 0.83 (0.68 to 0.95) |
| Contrast | 0.80 (0.66 to 0.90) |
| Sharp | 0.79 (0.67 to 0.89) |
| Skin | 0.84 (0.68 to 0.96) |
| Noise | 0.83 (0.69 to 0.95) |
| Artifact | 0.84 (0.69 to 0.95) |
| Mass | 0.63 (0.49 to 0.75) |
| Calcification | 0.87 (0.78 to 0.94) |
| Arch Distortion/Asymmetry | 0.64 (0.45 to 0.79) |
Collected over 5 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FBP (Old Processing) | 0/600 (0%) | 0/600 (0%) | 0/600 (0%) |
| ISR (New Processing) | 0/600 (0%) | 0/600 (0%) | 0/600 (0%) |
| Age, Categorical(Participants) | FBP (Old Processing)/ISR (New Processing) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 563 |
| >=65 years | 37 |
| Sex: Female, Male(Participants) | FBP (Old Processing)/ISR (New Processing) |
|---|---|
| Female | 600 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | FBP (Old Processing)/ISR (New Processing) |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 590 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | FBP (Old Processing)/ISR (New Processing) |
|---|---|
| United States | 600 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jun 2018 to primary completion in Jun 2018, 0 months.
Results were first posted in May 2020, 1 year 10 months after primary completion.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Fujifilm Medical Systems USA, Inc.