Breast Cancer, Tumors, Breast, Cancer Screening
Conditions
Brief summary
The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.
Detailed description
ADAPT program consists of 2 recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and data collected (ADAPT-BIE). This study involves the comparison of two devices that can identify abnormalities in routine breast screening and diagnostic mammography. Mammography is usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and other abnormal tissue. The purpose of this study is to learn more about the accuracy of full-field digital mammography devices and a new mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move around the breast to get X-ray images from different angles, which provides a three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects will undergo routine imaging with FFDM and will also have a DBT performed. They will continue with their standard of care treatment as would occur outside of the study. Based on the results of the FFDM and DBT, the subject's status will be followed-up with routing imaging at approximately 1 year (10-16 months). If the doctor recommends biopsy based on the FFDM or DBT, information about the biopsy and cancer determination results will be collected. Being in this study does not require subjects to have a biopsy that was not recommended by the doctor for normal medical care.
Interventions
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged 30 years or older (≥30 years old); * Asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days; * Mammography completed on a General Electric (GE) GE FFDM system (with craniocaudal (CC) and mediolateral oblique (MLO) views) at the site or another clinical facility; * Are able and willing to comply with study procedures; * Have signed and dated the informed consent form; * Are either surgically sterile or postmenopausal or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, a negative urine pregnancy test (if subject requests one).
Exclusion criteria
* Have been previously included in this study; * Have a history of breast cancer and are in active treatment. However, subjects with a prior lumpectomy (\> 5 years prior) who receive only routine screening mammography views can be included; * Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during either FFDM or DBT examination; * Have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes; * Have breast implant(s); * Have reconstructed breast(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Imaging Data Collected | within 30 days of enrollment | Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device Malfunctions by Modality (DBT or FFDM). | Duration of study -approximately 26 months | Number of device malfunctions by modality (DBT or FFDM) |
| Cancer-positive Participants | Duration of study - approximately 26 months | Participants confirmed to be positive for cancer on histology review. |
Countries
United States
Participant flow
Recruitment details
The subject population consisted of asymptomatic adult women (30 years of age or greater) scheduled for routine screening mammography.
Participants by arm
| Arm | Count |
|---|---|
| Mammography FFDM and DBT 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 | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Mammography FFDM and DBT |
|---|---|
| Age, Continuous | 57.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 250 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 250 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 250 Participants |
| Sex: Female, Male Female | 250 Participants |
| Sex: Female, Male Male | 0 Participants |
| Successfully completed FFDM and DBT scans | 249 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 250 |
| other Total, other adverse events | 2 / 250 |
| serious Total, serious adverse events | 0 / 250 |
Outcome results
Primary
Number of Participants With Imaging Data Collected
Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mammography FFDM and DBT | Number of Participants With Imaging Data Collected | Participants with images collected by both methods | 249 Participants |
| Mammography FFDM and DBT | Number of Participants With Imaging Data Collected | Participants with image collected by one method | 1 Participants |
Other Pre-specified
Cancer-positive Participants
Participants confirmed to be positive for cancer on histology review.
Time frame: Duration of study - approximately 26 months
Population: Participants who completed the study, including conclusive histology review, and cancer status was positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mammography FFDM and DBT | Cancer-positive Participants | 6 Participants |
Other Pre-specified
Device Malfunctions by Modality (DBT or FFDM).
Number of device malfunctions by modality (DBT or FFDM)
Time frame: Duration of study -approximately 26 months
Population: One device malfunction reported for FFDM; Zero device malfunctions reported for DBT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mammography FFDM and DBT | Device Malfunctions by Modality (DBT or FFDM). | Device malfunctions reported for FFDM | 1 Malfunctions |
| Mammography FFDM and DBT | Device Malfunctions by Modality (DBT or FFDM). | Device malfunctions reported for DBT | 0 Malfunctions |