Breast Cancer
Conditions
Brief summary
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).
Detailed description
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
Interventions
DEVICEFBP
Old processing
DEVICEISR
New processing
Sponsors
International HealthCare, LLC
Fujifilm Medical Systems USA, Inc.
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female subjects participating in FMSU2013-004A protocol with known clinical status
Exclusion criteria
* Female subjects that did not have known clinical status in FMSU2013-004A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of ISR (Modified Processing) to FBP (Original Processing) | 1 day reading session | 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) |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 600 |
| Total | 600 |
Baseline characteristics
| Characteristic | FBP (Old Processing)/ISR (New Processing) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 563 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 590 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Region of Enrollment United States | 600 participants |
| Sex: Female, Male Female | 600 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 600 | 0 / 600 |
| other Total, other adverse events | 0 / 600 | 0 / 600 |
| serious Total, serious adverse events | 0 / 600 | 0 / 600 |
Outcome results
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)
Time frame: 1 day reading session
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | MLO | 0.83 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Uniformity | 0.83 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Contrast | 0.80 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Sharp | 0.79 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Skin | 0.84 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Noise | 0.83 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Artifact | 0.84 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Mass | 0.63 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Calcification | 0.87 5-point scale |
| ISR (New Processing) | Comparison of ISR (Modified Processing) to FBP (Original Processing) | Arch Distortion/Asymmetry | 0.64 5-point scale |