Sonography of the Nipple Areolar Complex

March 28, 2025 updated by: Christine U. Lee, Mayo Clinic

Sonography of the Nipple Areolar Complex (SONAC) Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Subjects
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.
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.
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality satisfaction
Time Frame: 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).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound exam length of time
Time Frame: Baseline
The total number of minutes ultrasound is performed on the subjects.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Christine Lee, MD, PhD, Mayo Clinic
  • Principal Investigator: Shigao Chen, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Actual)

October 8, 2024

Study Completion (Actual)

October 8, 2024

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-004909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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