Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

FFDM Plus DBT

FFDM

Robert M Uzenoff

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.

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.

Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program

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

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.

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.

Fujifilm Medical Systems USA, Inc.

There were no AE's expected for this study, as it was a radiologist reader study utilizing retrospective imaging. No study subjects were on-site for this retrospective review. No Adverse Events to report.

Breast Images with FFDM and DBT

FFDM Plus DBT: FujiFilm Aspire Cristalle System

Breast Images with FFDM alone

FFDM: FujiFilm Aspire Cristalle System

Full-Field Digital Mammography

Each case contributed 2 sets of images: FFDM only as well as DBT plus FFDM. Therefore there were 200 reads acquired from the 100 cases/participants.

All 100 Cases/Study Participants

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

There were 100 study participants (resulting in 200 images) in total who had their images reviewed by 6 radiologist readers. Images were acquired under acquisition study FMSU2013-004A.

Randy Vader

Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.

This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).

Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.

This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).

Full-Field Digital Mammography (FFDM)

The study employed a fully factorial, counterbalanced crossover design in which all readers reviewed images from all cases in two visits separated by a memory washout period of approximately 4 weeks. Each reader read half FFDM cases and half FFDM + DBT cases during each of 2 visits.

Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate

Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.

Readers to read half of the FFDM plus DBT images followed by half of the FFDM only images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions.

FFDM Plus DBT, Then FFDM Only

Readers to read half of the FFDM only images followed by half of the FFDM plus DBT images at each of the 2 sessions. There was a 4 week memory washout period between the 2 sessions.

FFDM Only, Then FFDM Plus DBT

First Reading Session

4 Week Memory Washout Period

Second Reading Session

Breast Diseases

Skin Diseases

FFDM Plus DBT images are being evaluated as compared to FFDM alone

Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT

FFDM + DBT Images

FujiFilm Aspire Cristalle System

FFDM Alone

The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.

A Multi-Reader Multi-Case Pivotal Trial

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus DBT Versus FFDM Alone in the Detection of Breast Cancer

The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result.

FFDM Plus DBT images are being evaluated as compared to FFDM alone

FFDM Plus DBT: FFDM + DBT Images

FujiFilm Aspire Cristalle System

Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT

FFDM Alone: FFDM Alone Images

Full Field Digital Mammography

There were 298 study participants in total who had their images reviewed by 28 radiologist readers. Images were acquired under acquisition study FMSU2013-004A.

All 298 Cases/Study Participants

Full Field Digital Mammography (FFDM)

Twenty-eight qualified radiologists independently performed reads on all 298 cases. Each radiologist reader read each case sequentially, first as a FFDM read, and then FFDM + DBT read, all on the Aspire Bellus workstation.

Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization.

FFDM images are being evaluated as compared to FFDM Plus DBT

FujiFilm Aspire Cristalle System

This is a sequential read, each reader read the case as a FFDM read followed by a FFDM plus DBT read

FFDM Alone Then FFDM Plus DBT

Overall Study

The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.

This pilot reader study was to determine the following:

1. 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",;
2. the magnitude and direction of differences between performance metrics for the two modalities; and
3. 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.

Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone

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

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).

Breast Images with FFDM and DBT

FFDM Plus DBT: Fujifilm Aspire Cristalle System

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program	NCT02685566	Breast Cancer	FFDM Plus DBT FFDM	18 Years -	Fujifilm Medical Systems USA, Inc.
A Multi-Reader Multi-Case Pivotal Trial	NCT02692209	Breast Cancer	FFDM Plus DBT FFDM Alone	18 Years -	Fujifilm Medical Systems USA, Inc.
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone	NCT02511730	Breast Cancer	FFDM Plus DBT FFDM	18 Years -	Fujifilm Medical Systems USA, Inc.

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