Breast Carcinoma
Conditions
Brief summary
This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat. Molecular breast imaging (MBI) uses an injection of a small amount of radioactive material that is taken up in tissues of the body that are actively changing, such as breast cancer. A specialized camera, called a gamma camera, takes pictures of the gamma rays emitted by this material. MBI may detect cancers that are not visible on mammograms. This study may help researchers determine how MBI testing compares to DBT screening.
Detailed description
This study includes women age 40-75 who are presenting for breast cancer screening and had mammographically dense breasts on their last mammogram. Participants undergo annual DBT and MBI screening for two years. The primary aim for this study is to compare the rate of detection of invasive cancers between DBT alone vs. the combination of DBT with supplemental MBI at the first year of screening.
Interventions
PROCEDUREDigital Breast Tomosynthesis (DBT)
DBT is standard of care breast screening
RADIATIONScintimammography
Undergo MBI
Sponsors
Mayo Clinic
Susan G. Komen Breast Cancer Foundation
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient is a consenting female age 40-75 years * Patient is scheduled for routine screening DBT * Patient is asymptomatic for breast disease * Patient had heterogeneously dense or extremely dense breasts on most recent prior mammography examination (Breast Imaging Reporting and Data System \[BI-RADS\] c or d) within 24 months of enrollment * Patient is able to participate fully in all aspects of the study (completing study visits and study data collection) * Patient understands and signs the study informed consent * Patient anticipates being able to return one year after study enrollment to complete the second round of screening
Exclusion criteria
* Patient is currently pregnant or plans to become pregnant during the course of the study * Patient is currently lactating * Patient has had a prior MBI * Patient has had a prior whole breast ultrasound (WBUS) for screening, with either a hand-held ultrasound probe or automated system, within 12 months prior to study enrollment * Patient has had a prior breast MRI * Patient has had a prior contrast-enhanced mammogram (contrast enhanced spectral mammography \[CESM\] or contrast-enhanced digital mammography \[CEDM\]) * Patient is concurrently participating in any other breast imaging research studies that involve undergoing additional breast imaging tests beyond routine screening with mammography, including but not limited to contrast-enhanced mammography, WBUS, MBI, or contrast-enhanced breast MRI * Patient has had a breast biopsy within 3 months prior to study enrollment * Patient has had breast surgery within 12 months prior to study enrollment * Patient is currently undergoing treatment for breast cancer or planning surgery for a high-risk breast lesion (atypical ductal hyperplasia \[ADH\], atypical lobular hyperplasia \[ALH\], lobular carcinoma in situ \[LCIS\], papilloma, radial scar) * Patient is currently taking a chemoprevention agent for breast cancer risk reduction or osteoporosis prevention (tamoxifen, raloxifene, anastrazole, letrozole, exemestane) * Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Detection of Invasive Cancers | At year 1 screening | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarrie B. Hruska, M.D.
Mayo Clinic in Rochester
Participant flow
Recruitment details
Enrollment occurred from June 2017 to July 2022 through consecutive sampling.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2833 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 68 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 59 Participants |
| Race (NIH/OMB) Black or African American | 268 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 48 Participants |
| Race (NIH/OMB) White | 2592 Participants |
| Sex: Female, Male Female | 2978 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,978 |
| other Total, other adverse events | 0 / 2,978 |
| serious Total, serious adverse events | 0 / 2,978 |
Outcome results
None listed