Symptomatic Breast Lump
Conditions
Brief summary
Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.
Interventions
DEVICEPEFS system (Product Name: Intelligent Breast Exam™ or iBE™
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * Women and men with symptomatic breast lump (either by palpation or imaging) OR * Asymptomatic women presenting to the imaging center for a screening mammogram. * Signed Informed Consent
Exclusion criteria
* Patients under 18 years of age * Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Quadrants With Detected Breast Lesions | 3 months | The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12). |
| Sensitivity of iBE Breast Lesion Detection | 1 day | the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection |
| Specificity of iBE Breast Lesion Detection | 1 day | the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Breast Scanner PEFS system (Product Name: Intelligent Breast Exam™ or iBE™ | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missing iBE data: a result of incomplete data transfer from the iBE | 11 |
Baseline characteristics
| Characteristic | Breast Scanner |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Age, Continuous | 42 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 27 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 | 5 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment United States | 78 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
Primary
Number of Quadrants With Detected Breast Lesions
The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).
Time frame: 3 months
Population: the iBE result of each participant was broken into 4 quadrants for each breast. Some quadrants were missing iBE data. 78 participants and 342 quadrants, 77 is the number of quadrants with positive findings of the 78 participants and the 342 quadrants analyzed.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Breast Scanner | Number of Quadrants With Detected Breast Lesions | Number of quadrants positive for a lesion | 77 quadrants |
| Breast Scanner | Number of Quadrants With Detected Breast Lesions | Number of quadrants negative for a lesion | 265 quadrants |
Primary
Sensitivity of iBE Breast Lesion Detection
the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection
Time frame: 1 day
Population: quadrants with positive breast lesions
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Breast Scanner | Sensitivity of iBE Breast Lesion Detection | 66 quadrants |
Primary
Specificity of iBE Breast Lesion Detection
the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant
Time frame: 1 day
Population: breast quadrants negative for breast lesions
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Breast Scanner | Specificity of iBE Breast Lesion Detection | 237 quadrants |