Healthy
Conditions
Keywords
Nipple ultrasound imaging
Brief summary
The purpose of this study is to determine ultrasound scanning techniques of the nipple areolar complex (NAC) that provide optimal diagnostic imaging features.
Interventions
DIAGNOSTIC_TESTThin layer conventional ultrasound coupling gel
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.
DIAGNOSTIC_TESTThick layer of conventional ultrasound coupling gel
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.
DIAGNOSTIC_TESTThin conventional ultrasound coupling gel pad
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.
DIAGNOSTIC_TESTThick conventional ultrasound coupling gel pad
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality satisfaction | Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound exam length of time | Baseline | The total number of minutes ultrasound is performed on the subjects. |
Countries
United States
Outcome results
None listed