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Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.
This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABUS vs MRI (ultrasound when indicated) | Other | To compare the overall sensitivity and specificity of ABUS versus MRI (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients. |
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| ABUS vs mammography (ultrasound when indicated) | Other | To compare the sensitivity and specificity of ABUS versus mammography (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients when MRI is not performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABUS | Device | Automated breast ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging | Rate of detection of occult breast cancer by ABUS, otherwise missed by standard imaging (MRI or mammogram with hand-held breast ultrasound as clinically indicated). | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 1, 2018 | |
| Reset | Mar 28, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 1, 2018 | Mar 28, 2018 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |