Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/15/2018 |
| Start Date: | June 30, 2018 |
| End Date: | September 2018 |
A Feature Comparison Study to Evaluate the Modified Processing of Fujifilm's ASPIRE Cristalle With Digital Breast Tomosynthesis Option as Compared to the Original Processing
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).
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
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
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
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