Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586583
Recruitment Status : Completed
First Posted : July 13, 2018
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
International HealthCare, LLC
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Breast Cancer 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : June 30, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Comparison of ISR (Modified Processing) to FBP (Original Processing) [ Time Frame: 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)



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
600
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586583


Locations
Layout table for location information
United States, Connecticut
International HealthCare, LLC
Norwalk, Connecticut, United States, 06851
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
International HealthCare, LLC
Investigators
Layout table for investigator information
Study Director: Susan Crennan Fujifilm Medical Systems USA, Inc.
  Study Documents (Full-Text)

Documents provided by Fujifilm Medical Systems USA, Inc.:
Statistical Analysis Plan  [PDF] July 16, 2018
Study Protocol  [PDF] May 15, 2018

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier: NCT03586583    
Other Study ID Numbers: FMSU2017-003
First Posted: July 13, 2018    Key Record Dates
Results First Posted: May 20, 2020
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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