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| Name | Class |
|---|---|
| UE LifeSciences Inc. | INDUSTRY |
| Earlier.org | UNKNOWN |
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This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination.
The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening Visits for Breast Cancer | Experimental | Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Breast exam (CBE) | Other | The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding. |
|
| 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 scan |
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Inclusion Criteria:
Exclusion Criteria:
Breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Mango, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MSK at Ralph Lauren (All Protocol Activities) | New York | New York | 10035 | United States | ||
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| iBreastExam device | Device | The iBE is an FDA 510(k) cleared portable device which utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities. The iBE exam will be administered by a mammogram technologist, blinded to CBE results. |
|
| mammogram | Diagnostic Test | All patients will have routine standard mammographic views performed. Patients with positive iBE and/or CBE findings will have additional mammographic and/or ultrasound imaging to determine if a correlating breast lesion is present using the same standard of care algorithm as is used currently for positive CBE findings. |
|
| New York |
| New York |
| 10065 |
| United States |