Breast Cancer
Conditions
Keywords
breast cancer, imaging
Brief summary
The primary hypothesis to be tested is: The detection of breast cancer will be increased with tomosynthesis (3D) imaging
Detailed description
The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.
Interventions
DEVICETomosynthesis
The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
DEVICEConventional
conventional (2D) imaging (standard mammography)
Sponsors
Hologic, Inc.
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female * Any ethnic origin * No contraindication for routine bilateral mammography
Exclusion criteria
Potential subjects with any of the following will not be enrolled in the study: * Any contraindications to mammographic screening, including, but not limited to: * Significant existing breast trauma * Under the age of 30 at the time of consent * Breast Implants * Prior Surgeries * Unable to understand and execute written informed consent * Pregnant * Lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Breast Cancer (Sensitivity) | up to two years follow up for development of breast cancer | Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN) |
Countries
United States
Participant flow
Pre-assignment details
496 enrolled and 426 completed study, but no information available to distinguish study arms: 1. Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown). 2. Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms. | 496 |
| Total | 496 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 69 Participants |
| Age, Categorical Between 18 and 65 years | 427 Participants |
| Region of Enrollment United States | 248 participants |
| Sex: Female, Male Female | 496 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 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Detection of Breast Cancer (Sensitivity)
Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)
Time frame: up to two years follow up for development of breast cancer
Population: PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.