Trial Outcomes & Findings for Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study (NCT NCT03501693)

Last Updated: 2023-09-21

Results Overview

Average of each radiologist reader's ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject.

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

4 weeks

Results posted on

2023-09-21

Participant Flow

This was a retrospective, multi-reader multi-case reader study. 18 radiologist readers read all 300 cases (half FFDM and half DBT plus S-View reads) at each of 2 visits which were separated by a memory washout period of approximately 4 weeks. Images were previously acquired under Fujifilm protocol FMSU2013-004A.

Participant milestones

Participant milestones
Measure	DBT Plus S-View, Then FFDM Only Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.	FFDM Only, Then DBT Plus S-View Readers will read half of the FFDM images followed by half of the DBT plus S-Viewonly images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.
First Reading Session STARTED	75	75
First Reading Session COMPLETED	75	75
First Reading Session NOT COMPLETED	0	0
4 Week Memory Washout Period STARTED	75	75
4 Week Memory Washout Period COMPLETED	75	75
4 Week Memory Washout Period NOT COMPLETED	0	0
Second Reading Session STARTED	75	75
Second Reading Session COMPLETED	75	75
Second Reading Session NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBT Plus S-View and FFDM Alone n=300 Participants 300 retrospectively collected breast images to be reviewed (both DBT plus S-View and FFDM alone for all 300 images)
Age, Customized Particant Age Mean	56.5 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	300 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	260 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	24 Participants n=5 Participants
Race (NIH/OMB) White	270 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 300 images in their own randomized order during 2 sessions (they read half of each modality at each session which were separated by a 4 week washout period).

Outcome measures

Outcome measures
Measure	DBT Plus S-View n=300 Participants Breast images utilizing DBT plus S-View DBT plus S-View: DBT plus S-View images	FFDM Alone n=300 Participants FFDM alone images FFDM Alone: FFDM alone images
Compare Per Subject AUC: DBT Plus S-View Versus FFDM	0.794 Probability Standard Error 0.032	0.764 Probability Standard Error 0.035

SECONDARY outcome

Timeframe: 4 weeks

Population: 240 non-cancer cases evaluated out of 300 total cases acquired under Fujifilm protocol FMSU2013-004A.

Based on recall rate for all non-cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.05. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.

Outcome measures

Outcome measures
Measure	DBT Plus S-View n=240 Participants Breast images utilizing DBT plus S-View DBT plus S-View: DBT plus S-View images	FFDM Alone n=240 Participants FFDM alone images FFDM Alone: FFDM alone images
Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM	0.342 Proportion of cases correctly recalled Standard Error 0.026	0.415 Proportion of cases correctly recalled Standard Error 0.027

SECONDARY outcome

Timeframe: 4 weeks

Population: 60 cancer cases were read (out of the total of 300 cases) from the previously acquired Fujifilm FMSU2013-004A acquisition study.

Based on recall rate for all cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.

Outcome measures

Outcome measures
Measure	DBT Plus S-View n=60 Participants Breast images utilizing DBT plus S-View DBT plus S-View: DBT plus S-View images	FFDM Alone n=60 Participants FFDM alone images FFDM Alone: FFDM alone images
Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases	0.679 Proportion of cases correctly recalled Standard Error 0.048	0.643 Proportion of cases correctly recalled Standard Error 0.049

SECONDARY outcome

Timeframe: Four weeks

Population: Sensitivity was analyzed in 60 cancer cases.

Based on forced BI-RADS scores requiring correct lesion localization, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.

Outcome measures

Outcome measures
Measure	DBT Plus S-View n=60 Participants Breast images utilizing DBT plus S-View DBT plus S-View: DBT plus S-View images	FFDM Alone n=60 Participants FFDM alone images FFDM Alone: FFDM alone images
Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM	0.679 Probability Standard Error 0.048	0.643 Probability Standard Error 0.049

Adverse Events

DBT Plus S-View

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FFDM Alone

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