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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA199044 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.
The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose.
The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dedicated breast computed tomography (BCT) | Experimental | All subjects will undergo bilateral breast CT (BCT) imaging exam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dedicated breast CT(BCT) | Diagnostic Test | The breast CT device will take multiple pictures of the subject's uncompressed breast and creates a 3-D image of the breast. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | The diagnostic accuracy of BCT will be determined from a multi-reader, multi-case reader study. | 12 months after completion of accrual |
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Inclusion criteria: All subjects that are eligible to participate in the study will be women who satisfy all of the inclusion criteria stated below:
Exclusion criteria: Subjects that present with any of the criteria listed below will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Galvan, R.T.R. | Contact | 520-626-2279 | mngalvan@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Srinivasan Vedantham, PhD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85724 | United States |
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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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All subjects will undergo a bilateral breast CT (BCT) exam.
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|
| D017437 |
| Skin and Connective Tissue Diseases |