Sonography of the Nipple Areolar Complex

NCT06441188 | Completed

• 1 other identifier: 24-004909
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Nipple ultrasound imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ultrasound exam length of time

  Baseline

Study Arms (1)

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.

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

Interventions

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.

Healthy Subjects

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.

Healthy Subjects

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.

Healthy Subjects

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.

Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, Age of 18 or older; no breast cancer; no breast symptom.

You may not qualify if:

• Subjects lacking capacity to consent; vulnerable subjects such as prisoners.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Christine Lee, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Shigao Chen, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: September 10, 2024
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)