Trial Outcomes & Findings for Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (NCT NCT02306265)

Last Updated: 2019-01-29

Results Overview

Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.

Recruitment status

COMPLETED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

within 30 days of enrollment

Results posted on

2019-01-29

Participant Flow

The subject population consisted of asymptomatic adult women (30 years of age or greater) scheduled for routine screening mammography.

Participant milestones

Participant milestones
Measure	Mammography FFDM and DBT All subjects were expected to undergo 2D breast imaging with full-field digital mammography (FFDM) and 3D breast imaging with digital breast tomosynthesis (DBT). The order in which these scans took place was not assigned. Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
Overall Study STARTED	250
Overall Study COMPLETED	249
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Mammography FFDM and DBT All subjects were expected to undergo 2D breast imaging with full-field digital mammography (FFDM) and 3D breast imaging with digital breast tomosynthesis (DBT). The order in which these scans took place was not assigned. Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mammography FFDM and DBT n=250 Participants All subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Order for scan method was not assigned. Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
Age, Continuous	57.4 years n=5 Participants
Sex: Female, Male Female	250 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	250 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	250 Participants n=5 Participants
Region of Enrollment United States	250 Participants n=5 Participants
Successfully completed FFDM and DBT scans	249 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 30 days of enrollment

Population: The efficacy population for primary outcome were subjects meeting study inclusion/exclusion criteria with no protocol violations judged to affect the ability to evaluate the subject, whose DBT/FFDM images were diagnostically evaluable and whose mammography images were available for independent blinded evaluation, regardless of image quality.

Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.

Outcome measures

Outcome measures
Measure	Mammography FFDM and DBT n=250 Participants Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
Number of Participants With Imaging Data Collected Participants with images collected by both methods	249 Participants
Number of Participants With Imaging Data Collected Participants with image collected by one method	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of study -approximately 26 months

Population: One device malfunction reported for FFDM; Zero device malfunctions reported for DBT.

Number of device malfunctions by modality (DBT or FFDM)

Outcome measures

Outcome measures
Measure	Mammography FFDM and DBT n=250 Participants Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
Device Malfunctions by Modality (DBT or FFDM). Device malfunctions reported for FFDM	1 Malfunctions
Device Malfunctions by Modality (DBT or FFDM). Device malfunctions reported for DBT	0 Malfunctions

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of study - approximately 26 months

Population: Participants who completed the study, including conclusive histology review, and cancer status was positive.

Participants confirmed to be positive for cancer on histology review.

Outcome measures

Outcome measures
Measure	Mammography FFDM and DBT n=188 Participants Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
Cancer-positive Participants	6 Participants

Adverse Events

Mammography FFDM and DBT

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mammography FFDM and DBT n=250 participants at risk Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device Full-Field Digital Mammogram: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
Skin and subcutaneous tissue disorders Rash	0.80% 2/250 • Time frame in which subjects were to complete the two scan types (up to 30 days). Adverse Event (AE): As defined by European Norms International Standard Organization (EN ISO) ISO 14155-2011: any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.

Additional Information

Sara Lam

GE Healthcare

Phone: 1-262-548-2369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place