Sonography of the Nipple Areolar Complex

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: Thin layer conventional ultrasound coupling gel; Diagnostic Test: Thick layer of conventional ultrasound coupling gel; Diagnostic Test: Thin conventional ultrasound coupling gel pad; Diagnostic Test: Thick conventional ultrasound coupling gel pad

• Registration Number: NCT06441188
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-04
• Study Start: 2024-09-10
• Primary Completion: 2024-10-08
• Study Completion: 2024-10-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	Thick layer of conventional ultrasound coupling gel	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.
Healthy Subjects	Thick conventional ultrasound coupling gel pad	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.
Healthy Subjects	Thin layer conventional ultrasound coupling gel	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.
Healthy Subjects	Thin conventional ultrasound coupling gel pad	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Ultrasound exam length of time	Baseline	The total number of minutes ultrasound is performed on the subjects.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States