Trial Outcomes & Findings for Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue (NCT NCT03220893)
NCT ID: NCT03220893
Last Updated: 2026-02-20
Results Overview
Compare the rate of detection of invasive cancers between DBT alone versus (vs.) the combination of digital breast tomosynthesis (DBT) with supplemental molecular breast imaging (MBI) at initial (year 1) screening. For each modality, the detection rate of invasive cancers will be estimated as the proportion of participants in the analysis set who had an invasive cancer detected by the modality and verified by pathology.
COMPLETED
NA
3023 participants
At year 1 screening
2026-02-20
Participant Flow
Enrollment occurred from June 2017 to July 2022 through consecutive sampling.
Participant milestones
| Measure |
All Participants
All participants are screened with DBT and MBI
|
|---|---|
|
DBT Alone
STARTED
|
2978
|
|
DBT Alone
COMPLETED
|
2978
|
|
DBT Alone
NOT COMPLETED
|
0
|
|
DBT + MBI
STARTED
|
2978
|
|
DBT + MBI
COMPLETED
|
2978
|
|
DBT + MBI
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue
Baseline characteristics by cohort
| Measure |
All Participants
n=2978 Participants
All participants are screened with DBT and MBI
|
|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 9.3 • n=14 Participants
|
|
Sex: Female, Male
Female
|
2978 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
268 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
2592 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
48 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
77 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2833 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
68 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: At year 1 screeningPopulation: Of 2978 participants screened with DBT alone and with DBT + supplemental MBI, 23 participants had invasive breast cancer detected.
Compare the rate of detection of invasive cancers between DBT alone versus (vs.) the combination of digital breast tomosynthesis (DBT) with supplemental molecular breast imaging (MBI) at initial (year 1) screening. For each modality, the detection rate of invasive cancers will be estimated as the proportion of participants in the analysis set who had an invasive cancer detected by the modality and verified by pathology.
Outcome measures
| Measure |
Observational (MBI, DBT)
n=23 Participants
Participants undergo DBT and MBI at year 0 and year 1 screening.
|
|---|---|
|
Rate of Detection of Invasive Cancers
Invasive cancers detected by DBT alone
|
9 Participants
|
|
Rate of Detection of Invasive Cancers
Additional invasive cancers detected by supplemental MBI
|
14 Participants
|
Adverse Events
All Participants
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