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The purpose of this study is to determine ultrasound scanning techniques of the nipple areolar complex (NAC) that provide optimal diagnostic imaging features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Experimental | Healthy volunteers with no breast cancer or breast symptoms. Subjects will undergo 1 hour of non-invasive ultrasound scanning of the nipple and its adjacent tissues. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thin layer conventional ultrasound coupling gel | Diagnostic Test | The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thin layer of conventional ultrasound coupling gel. |
| Measure | Description | Time Frame |
|---|---|---|
| Image quality satisfaction | Images will be ranked by three independent radiologists and scored from 1 to 4 respectively (1 is the least satisfactory, 4 is the most satisfactory). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound exam length of time | The total number of minutes ultrasound is performed on the subjects. | Baseline |
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Inclusion Criteria:
Female, Age of 18 or older; no breast cancer; no breast symptom.
Exclusion Criteria:
Subjects lacking capacity to consent; vulnerable subjects such as prisoners.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Christine Lee, MD, PhD | Mayo Clinic | Principal Investigator |
| Shigao Chen, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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|
| Thick layer of conventional ultrasound coupling gel | Diagnostic Test | The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thick layer of conventional ultrasound coupling gel. |
|
| Thin conventional ultrasound coupling gel pad | Diagnostic Test | The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thin conventional ultrasound coupling gel pad. |
|
| Thick conventional ultrasound coupling gel pad | Diagnostic Test | The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thick conventional ultrasound coupling gel pad. |
|