Trial Outcomes & Findings for Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program (NCT NCT02685566)

Last Updated: 2023-09-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

4 weeks

Results posted on

2023-09-21

Participant Flow

The 100 breast screening and diagnostic cases selected for this study, were obtained from the FMSU2013-004A acquisition study. The statistician randomly selected cases to provide a distribution of density, finding types, etc.

Each radiologist read all 100 cases as FFDM only and FFDM+DBT(100 cases multiplied by 2 modalities = 200 reads) with a 4 week washout period between the 2 sessions.

Participant milestones

Participant milestones
Measure	FFDM Plus DBT, Then FFDM Only 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 Only, Then FFDM Plus DBT 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.
First Reading Session STARTED	50	50
First Reading Session COMPLETED	50	50
First Reading Session NOT COMPLETED	0	0
4 Week Memory Washout Period STARTED	50	50
4 Week Memory Washout Period COMPLETED	50	50
4 Week Memory Washout Period NOT COMPLETED	0	0
Second Reading Session STARTED	50	50
Second Reading Session COMPLETED	50	50
Second Reading Session NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All 100 Cases/Study Participants n=100 Participants 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.
Age, Continuous	58 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	FFDM Plus DBT n=100 Participants 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).	Full-Field Digital Mammography (FFDM) n=100 Participants 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).
Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate	.805 probability Interval 0.701 to 0.91	0.756 probability Interval 0.646 to 0.867

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FFDM Plus DBT n=100 Participants 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).	Full-Field Digital Mammography (FFDM) n=100 Participants 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).
Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.	0.805 Probability Interval 0.701 to 0.91	0.777 Probability Interval 0.659 to 0.894

Adverse Events

FFDM Plus DBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Full-Field Digital Mammography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Randy Vader

Fujifilm Medical Systems USA, Inc.

Phone: 360-356-6821

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place