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| Name | Class |
|---|---|
| UE LifeSciences Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intelligent Breast Exam, iBE | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intelligent Breast Exam, iBE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | approximately one month after imaging scan |
| 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 | approximately one month after imaging |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | approximately one month after imaging |
| Size Detection of the Breast Lesions Identified by iBE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ari D Brooks, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32031433 | Derived | Clanahan JM, Reddy S, Broach RB, Rositch AF, Anderson BO, Wileyto EP, Englander BS, Brooks AD. Clinical Utility of a Hand-Held Scanner for Breast Cancer Early Detection and Patient Triage. JCO Glob Oncol. 2020 Feb;6:27-34. doi: 10.1200/JGO.19.00205. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients analyzed were those who completed all exams required by the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of true positive lesions | approximately one month after imaging scan |
|
All participants were monitored for adverse events during a single visit, up to 1 hour.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ari D Brooks | Penn Medicine | 215-829-8461 | ari.brooks@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2014 | Oct 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
The size detected of the breast lesion (cm) by mammogram or ultrasound |
| approximately one month after imaging |
| 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 | through study completion an average of 18 months |
| 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 | through study completion an average of 18 months |
| 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 | through study completion an average of 18 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
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| 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 | Posted | Number | percentage of true negative lesions | approximately one month after imaging |
|
|
|
| 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. | Number of subjects who had a lesion identified by iBE and mammogram, ultrasound, or MRI. | Posted | Count of Units | lesions | approximately one month after imaging | lesions | lesions |
|
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| Secondary | Size Detection of the Breast Lesions Identified by iBE | The size detected of the breast lesion (cm) by mammogram or ultrasound | 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. | Posted | approximately one month after imaging | lesions | 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 | 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. | Posted | through study completion an average of 18 months |
|
|
| 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 | 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. | Posted | through study completion an average of 18 months |
|
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| 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 | The specificity of iBE relevant findings (BIRADs 0, 3-5) vs benign findings (BIRADS 1, 2) from the results of mammography | Posted | Count of Participants | Participants | through study completion an average of 18 months |
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| 0 |
| 486 |
| 0 |
| 486 |
| 0 |
| 486 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| iBE flase negative findings |
|