Expired Study
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Norwalk, Connecticut 06851


Purpose:

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 summary:

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


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


Study is Available At:


Original ID:

FMSU2017-003


NCT ID:

NCT03586583


Secondary ID:


Study Acronym:


Brief Title:

Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fujifilm Medical Systems USA, Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

600


Enrollment Type:

Actual


Study Dates

Start Date:June 30, 2018
Completion Date:September 2018
Completion Type:Anticipated
Primary Completion Date:June 30, 2018
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 2, 2018
First Received Date:July 2, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Non-inferior
Time Frame:1 day reading session
Safety Issues:False
Description:For each reader, the proportion of cases judged as non-inferior with modified processing will be calculated for each feature and each view

Study Interventions

Intervention Type:Device
Name:FBP
Description:Old processing
Arm Name:FBP (old processing)
Intervention Type:Device
Name:ISR
Description:New processing
Arm Name:ISR (new processing)

Study Arms

Study Arm Type:Experimental
Arm Name:ISR (new processing)
Description:Iterative super resolution; new processing.
Study Arm Type:Active Comparator
Arm Name:FBP (old processing)
Description:Filtered back projection; old processing.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Fujifilm Medical Systems USA, Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:International HealthCare, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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