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NCT06441188 Clinical Trial

Sonography of the Nipple Areolar Complex

Healthy Clinical Trial

Official title:
Sonography of the Nipple Areolar Complex (SONAC) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06441188
Other study ID # 24-004909
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 5, 2024
Est. completion date March 1, 2025

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine ultrasound scanning techniques of the nipple areolar complex (NAC) that provide optimal diagnostic imaging features.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date March 1, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Thin 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.
• Thick 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.
• Thin 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.
• Thick 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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary Ultrasound exam length of time The total number of minutes ultrasound is performed on the subjects. Baseline
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