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

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: FBP; Device: ISR

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

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • International HealthCare, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

600

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FBP (old processing); Filtered back projection; old processing.	Device: FBP; Old processing
ISR (new processing); Iterative super resolution; new processing.	Device: ISR; New processing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fujifilm Medical Systems USA, Inc.
• Collaborators: International HealthCare, LLC
• Investigators: Study Director: Susan Crennan, Fujifilm Medical Systems USA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): November 19, 2018

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FMSU2017-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No