Back to resultsPilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FFDM Plus DBT
FFDM
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Mammography
Eligibility Criteria
Inclusion Criteria:
- Female subjects participating in FMSU004A protocol with known clinical status
Exclusion Criteria:
- Subjects with unknown clinical status not participating in FMSU004A protocol.
Sites / Locations
- Scottsdale Medical Imaging, Limited (SMIL)
- Elizabeth Wende Breast Care, LLC (EWBC)
- University of North Carolina - at Chapel Hill
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FFDM Plus DBT
FFDM Alone
Arm Description
Breast Images with FFDM and DBT
Breast Images with FFDM alone
Outcomes
Primary Outcome Measures
Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM
Breast AUC performance metrics to determine if FFDM plus DBT improved cancer detection rate, requiring correct lesion localization. Statistician to estimate AUCs for each reader in each review condition (FFDM read in conjunction with FFDM plus DBT read) based on their Probability of Malignancy (POM) scores. POM scores will require correct lesion localization, such that in a case with cancer if the reader recorded one or more findings in the case but none of them are determined by the truther to match the location(s) of any proven malignancies, a POM score of 0 will be assigned to the case. Statistician to provide graphical representations of each reader's ROC curve for each review condition. For each reader the difference between the AUC for the FFDM read in conjunction with the FFDM plus DBT will be presented. Statistician to perform MRMC comparison of AUC's between FFDM read in conjunction with FFDM plus DBT using the MRMC method of Dorfman, Berbaum & Metz (1992).
Secondary Outcome Measures
Full Information
NCT ID
NCT02511730
First Posted
July 23, 2015
Last Updated
September 15, 2023
Sponsor
Fujifilm Medical Systems USA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02511730
Brief Title
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
Official Title
A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm Full Field Digital Mammography (FFDM) Plus Digital Breast Tomosynthesis (DBT) Versus FFDM Alone in the Detection of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujifilm Medical Systems USA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.
Detailed Description
This pilot reader study was to determine the following:
the radiologist's performance metrics for the two reading modalities, i.e., "FFDM read on the Aspire Bellus workstation" and "FFDM read in conjunction with DBT read on the Aspire Bellus workstation",;
the magnitude and direction of differences between performance metrics for the two modalities; and
variance components and correlations that would influence samples sizes and case mix for the subsequent pivotal reader study comparing performance metrics between the two modalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Mammography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FFDM Plus DBT
Arm Type
Experimental
Arm Description
Breast Images with FFDM and DBT
Arm Title
FFDM Alone
Arm Type
Active Comparator
Arm Description
Breast Images with FFDM alone
Intervention Type
Device
Intervention Name(s)
FFDM Plus DBT
Intervention Description
FujiFilm Aspire Cristalle System
Intervention Type
Device
Intervention Name(s)
FFDM
Intervention Description
FujiFilm Aspire Cristalle System
Primary Outcome Measure Information:
Title
Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM
Description
Breast AUC performance metrics to determine if FFDM plus DBT improved cancer detection rate, requiring correct lesion localization. Statistician to estimate AUCs for each reader in each review condition (FFDM read in conjunction with FFDM plus DBT read) based on their Probability of Malignancy (POM) scores. POM scores will require correct lesion localization, such that in a case with cancer if the reader recorded one or more findings in the case but none of them are determined by the truther to match the location(s) of any proven malignancies, a POM score of 0 will be assigned to the case. Statistician to provide graphical representations of each reader's ROC curve for each review condition. For each reader the difference between the AUC for the FFDM read in conjunction with the FFDM plus DBT will be presented. Statistician to perform MRMC comparison of AUC's between FFDM read in conjunction with FFDM plus DBT using the MRMC method of Dorfman, Berbaum & Metz (1992).
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female subjects participating in FMSU004A protocol with known clinical status
Exclusion Criteria:
Subjects with unknown clinical status not participating in FMSU004A protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Uzenoff
Organizational Affiliation
Fujifilm Medical Systems USA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Medical Imaging, Limited (SMIL)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Elizabeth Wende Breast Care, LLC (EWBC)
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of North Carolina - at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
We'll reach out to this number within 24 hrs