Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Filtered back projection; old processing.

Iterative super resolution; new processing.

Susan Crennan

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

Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing

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

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)

International HealthCare, LLC

Fujifilm Medical Systems USA, Inc.

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.

This was a reader study where radiologists/readers compared processing of previously acquired images.

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.

FBP (Old Processing)/ISR (New Processing)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Randy Vader

Uniformity

Contrast

Sharp

Skin

Noise

Artifact

Mass

Calcification

Arch Distortion/Asymmetry

Iterative super resolution; new processing.

ISR: New processing

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).

Comparison of ISR (Modified Processing) to FBP (Original 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.

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Spots Global Cancer Trial Database for fbp

Every month we try and update this database with for fbp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fbp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.