Breast Abnormalities
Conditions
Keywords
digital breast tomosynthesis, baseline screening mammography, recall rates
Brief summary
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.
Detailed description
The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.
Interventions
DEVICEtomosynthesis and screening mammography
All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Women between the ages of 34 and 56. * Women presenting for their baseline screening mammography examination
Exclusion criteria
* Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE). * Women who may be or are pregnant by self report * Women older than 55 years of age or younger than 35. * Women with known fatty breast tissue * Males and children * Women who are unable to understand or execute written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Without Cancer Who Were Recalled | upon recruitment/enrollment phase completion | Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Three subjects were deemed ineligible. Two subjects were withdrawn by the PI after beginning research procedures.
Participants by arm
| Arm | Count |
|---|---|
| Digital Breast Tomosynthesis (DBT) Consented and eligible women undergoing baseline screening mammography received DBT | 1,080 |
| Total | 1,080 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | deemed ineligible after screening | 3 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Digital Breast Tomosynthesis (DBT) |
|---|---|
| Age, Continuous | 42.03 years STANDARD_DEVIATION 3.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1054 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 35 Participants |
| Race (NIH/OMB) Black or African American | 278 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 751 Participants |
| Region of Enrollment United States | 1080 participants |
| Sex: Female, Male Female | 1080 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,080 |
| serious Total, serious adverse events | 0 / 1,080 |
Outcome results
Primary
Number of Participants Without Cancer Who Were Recalled
Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
Time frame: upon recruitment/enrollment phase completion
Population: Includes only participants who were not diagnosed as having a breast malignancy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Number of Participants Without Cancer Who Were Recalled | 274 participants |