Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
September 15, 2023 updated by: Fujifilm Medical Systems USA, Inc.
A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For this reader study, radiologists review images obtained via protocol FMSU2013-004A.
They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each.
The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85258
- Scottsdale Medical Imaging, Limited (SMIL)
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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New York
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Rochester, New York, United States, 14620
- Elizabeth Wende Breast Care, LLC (EWBC)
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina - at Chapel Hill
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Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female subjects participating in FMSU004A protocol with known clinical status
Exclusion Criteria:
- Subjects with unknown clinical status not participating in FMSU004A protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FFDM Plus DBT
Breast Images with FFDM and DBT
|
FujiFilm Aspire Cristalle System
|
|
Active Comparator: Full-Field Digital Mammography
Breast Images with FFDM alone
|
FujiFilm Aspire Cristalle System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate
Time Frame: 4 weeks
|
This endpoint was evaluated qualitatively.
Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate).
Per-subject BI-RADS, POM and recall scores were derived.
Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer.
Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.
Time Frame: 5 weeks
|
The magnitude and direction of differences between performance metrics for the two modalities, and variance components and correlations that would influence sample size and case mix for the pivotal reader study (FMSU2013-004G) comparing performance metrics between the two modalities, obtained using established methods for analysis of MRMC (multi-reader, multi-case) studies.
The statistician estimated AUC's for each reader in each review condition based on per-subject POM scores requiring correct lesion localization.
Statistician performed MRMC comparison of AUC's between reading conditions using the MRMC analysis of variance (ANOVA) method.
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Robert M Uzenoff, Fujifilm Medical Systems USA, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
August 17, 2015
First Submitted That Met QC Criteria
February 17, 2016
First Posted (Estimated)
February 18, 2016
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
Keywords
Other Study ID Numbers
- FMSU2013-004F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.