Trial Outcomes & Findings for Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone (NCT NCT02511730)

NCT ID: NCT02511730

Last Updated: 2023-09-21

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 1 month
• 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

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
Session Reading Session STARTED	50	50
Session Reading Session COMPLETED	50	50
Session Reading Session NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

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, Customized Participant Age	58 years STANDARD_DEVIATION 10.3 • n=93 Participants
Sex: Female, Male Female	100 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=93 Participants
Race/Ethnicity, Customized White	87 Participants n=93 Participants
Race/Ethnicity, Customized Other/Unknown	2 Participants n=93 Participants
Region of Enrollment United States	100 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month

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.

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).

Outcome measures

Measure	FFDM Plus DBT n=100 Participants Breast Images with FFDM and DBT FFDM Plus DBT: Fujifilm Aspire Cristalle System	FFDM n=100 Participants Breast Images with FFDM alone FFDM: Fujifilm Aspire Cristalle System
Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM	100 Probability Standard Error 0.812	100 Probability Standard Error 0.780

Adverse Events

FFDM Plus DBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FFDM

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