Trial Outcomes & Findings for Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment (NCT NCT01106911)

Last Updated: 2016-03-25

Results Overview

Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.

Recruitment status

COMPLETED

Study phase

Target enrollment

1080 participants

Primary outcome timeframe

upon recruitment/enrollment phase completion

Results posted on

2016-03-25

Participant Flow

Subjects were consented, screened and enrolled at one site, a medical hospital specializing in women's health. The period of recruitment was from May, 2010 to September, 2014.

Three subjects were deemed ineligible. Two subjects were withdrawn by the PI after beginning research procedures.

Participant milestones

Participant milestones
Measure	Digital Breast Tomosynthesis (DBT) Consented and eligible women undergoing baseline screening mammography received DBT
Overall Study STARTED	1085
Overall Study COMPLETED	1080
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Digital Breast Tomosynthesis (DBT) Consented and eligible women undergoing baseline screening mammography received DBT
Overall Study Physician Decision	2
Overall Study deemed ineligible after screening	3

Baseline Characteristics

Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Digital Breast Tomosynthesis (DBT) n=1080 Participants Consented and eligible women undergoing baseline screening mammography received DBT
Age, Continuous	42.03 years STANDARD_DEVIATION 3.75 • n=99 Participants
Sex: Female, Male Female	1080 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1054 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	35 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	278 Participants n=99 Participants
Race (NIH/OMB) White	751 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=99 Participants
Region of Enrollment United States	1080 participants n=99 Participants

PRIMARY outcome

Timeframe: upon recruitment/enrollment phase completion

Population: Includes only participants who were not diagnosed as having a breast malignancy.

Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.

Outcome measures

Outcome measures
Measure	Digital Breast Tomosynthesis (DBT) n=1074 Participants Consented and eligible women undergoing baseline screening mammography received DBT
Number of Participants Without Cancer Who Were Recalled	274 participants

Adverse Events

Digital Breast Tomosynthesis (DBT)

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

Dr. Jules H. Sumkin

University of Pittsburgh

Phone: 412-641-1976

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place