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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01CA091713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:
1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)
2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether:
1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone.
2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging scans for breast cancer screening | To simulate the performance of the combination of three new breast imaging systems to digital mammography and hand-held ultrasound that are currently used to find and evaluate breast masses. These three different systems make images of the breast in several ways to find breast masses and to distinguish normal and abnormal masses. This may result in less unnecessary call-backs from mammography. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-ray and ultrasound imaging scanning | Procedure | Digital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of new breast imaging devices | To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determining the ratio of "patient call backs" | To determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes women who have had a mammogram at University of Michigan within one year who have been referred to the study. Participants may have a breast mass, either benign or cancerous.
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| Name | Affiliation | Role |
|---|---|---|
| Paul L Carson, PhD | Univ. of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D047688 | Breast Cyst |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| Photoacoustic imaging scans for breast cancer screening | Procedure | The participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast. |
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| Skin and Connective Tissue Diseases |
| D009371 | Neoplasms by Site |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |