Trial Outcomes & Findings for Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer (NCT NCT03491917)
NCT ID: NCT03491917
Last Updated: 2020-06-18
Results Overview
Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al.
COMPLETED
100 participants
2 visits with 4 week washout period
2020-06-18
Participant Flow
This was a retrospective, multi-reader multi-case reader study. Six (6) radiologist readers read all 100 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
| Measure |
DBT Plus S-View
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 Alone
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.
|
|---|---|---|
|
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
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
Baseline characteristics by cohort
| Measure |
DBT Plus S-View and FFDM Alone
n=100 Participants
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.
|
|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 visits with 4 week washout periodPopulation: Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 100 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).
Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al.
Outcome measures
| Measure |
DBT Plus S-View
n=100 Participants
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 Alone
n=100 Participants
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.
|
|---|---|---|
|
Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)
|
0.819 Probability
Interval 0.719 to 0.919
|
0.796 Probability
Interval 0.7 to 0.891
|
Adverse Events
DBT Plus S-View
FFDM Alone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place