Trial Outcomes & Findings for A Multi-Reader Multi-Case Pivotal Trial (NCT NCT02692209)

NCT ID: NCT02692209

Last Updated: 2020-07-07

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 298 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2020-07-07

Participant Flow

The 298 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.

Reading radiologists independently read all 298 cases sequentially; first as an FFDM read, then as a FFDM + DBT read on the Aspire Bellus workstation. There was no washout, and all data below is entered correctly.

Participant milestones

Measure	FFDM Alone Then FFDM Plus DBT 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
Overall Study STARTED	298
Overall Study COMPLETED	298
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Reader Multi-Case Pivotal Trial

Baseline characteristics by cohort

Measure	All 298 Cases/Study Participants n=298 Participants There were 298 study participants in total who had their images reviewed by 28 radiologist readers. Images were acquired under acquisition study FMSU2013-004A.
Age, Continuous	59 years n=93 Participants
Sex: Female, Male Female	298 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	23 Participants n=93 Participants
Race (NIH/OMB) White	269 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	298 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 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.

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.

Outcome measures

Measure	FFDM Plus DBT n=298 Participants FFDM Plus DBT images are being evaluated as compared to FFDM alone FFDM Plus DBT: FFDM + DBT Images FujiFilm Aspire Cristalle System	Full Field Digital Mammography (FFDM) n=298 Participants Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT FFDM Alone: FFDM Alone Images
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.	0.837 Probability Interval 0.788 to 0.886	0.784 Probability Interval 0.726 to 0.841

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: randy.vader@fujifilm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place