Breast Cancer
Conditions
Keywords
breast lump, breast exam, breast cancer screening, breast lump detection
Brief summary
The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.
Detailed description
The FDA approved class II device in this clinical trial is a low-cost hand-held breast scanner (intelligent Breast Exam, iBE). This device is to be used a pre-screening tool for mammograms or ultrasounds. Determination of the accuracy of iBE for the detection of clinically relevant breast lesions will be performed by means of a prospective study. The iBE evaluation will be performed by a trained licensed practical nurse or ultrasound technologist who is blinded to the outcome of the radiology studies at the time the iBE is performed. The iBE training will be done by the leading iBE user in the United States. The iBE evaluation will be done prior to the patient's original scheduled imaging visit. After the completion of the imaging visit the radiologist will evaluate the mammogram and/or ultrasound images along with the iBE report.
Interventions
DEVICEintelligent Breast Exam, iBE
A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.
Sponsors
UE LifeSciences Inc.
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
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 |
|---|---|---|
| Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results | approximately one month after imaging scan | comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE |
| Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results | approximately one month after imaging | comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected | through study completion an average of 18 months | comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam |
| Position of the Breast Lesion as Measured by iBE and Mammography | approximately one month after imaging | agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other. |
| Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level | through study completion an average of 18 months | breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results |
| Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected | through study completion an average of 18 months | comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam |
| Size Detection of the Breast Lesions Identified by iBE | approximately one month after imaging | The size detected of the breast lesion (cm) by mammogram or ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intelligent Breast Exam, iBE Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.
intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit. | 486 |
| Total | 486 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | testing incomplete | 30 |
Baseline characteristics
| Characteristic | Intelligent Breast Exam, iBE |
|---|---|
| Age, Continuous | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 468 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 153 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 312 Participants |
| Region of Enrollment United States | 486 Participants |
| Sex: Female, Male Female | 486 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 486 |
| other Total, other adverse events | 0 / 486 |
| serious Total, serious adverse events | 0 / 486 |
Outcome results
Primary
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
Time frame: approximately one month after imaging
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intelligent Breast Exam, iBE | Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results | 80.3 percentage of true negative lesions |
Primary
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
Time frame: approximately one month after imaging scan
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intelligent Breast Exam, iBE | Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results | 34.3 percentage of true positive lesions |
Secondary
Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected
comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
Time frame: through study completion an average of 18 months
Population: Difficulty enrolling patients for this outcome as a result of the participants undergoing the iBE and CBE twice by two different healthcare professionals. Subjects declined to continue after first healthcare professional exams was complete. Comparison data between healthcare professionals was not available to analyze.
Secondary
Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected
comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
Time frame: through study completion an average of 18 months
Population: Difficulty enrolling patients for this outcome as a result of the participants undergoing the iBE and CBE twice by two different healthcare professionals. Subjects declined to continue after first healthcare professional exams was complete. Comparison data between healthcare professionals was not available to analyze.
Secondary
Position of the Breast Lesion as Measured by iBE and Mammography
agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other.
Time frame: approximately one month after imaging
Population: Number of subjects who had a lesion identified by iBE and mammogram, ultrasound, or MRI.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Intelligent Breast Exam, iBE | Position of the Breast Lesion as Measured by iBE and Mammography | 4 lesions |
Secondary
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level
breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results
Time frame: through study completion an average of 18 months
Population: The specificity of iBE relevant findings (BIRADs 0, 3-5) vs benign findings (BIRADS 1, 2) from the results of mammography
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intelligent Breast Exam, iBE | Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level | iBE true positive findings | 12 Participants |
| Intelligent Breast Exam, iBE | Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level | iBE true negative findings | 362 Participants |
| Intelligent Breast Exam, iBE | Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level | iBE false positive findings | 89 Participants |
| Intelligent Breast Exam, iBE | Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level | iBE flase negative findings | 23 Participants |
Secondary
Size Detection of the Breast Lesions Identified by iBE
The size detected of the breast lesion (cm) by mammogram or ultrasound
Time frame: approximately one month after imaging
Population: The size was not measured by iBE. Only 4 of the 7 lesions were detected by iBE and size data was not available to analyze.