A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer

NCT05408260 | Completed

• 2 other identifiers: 19D.799JT 14405
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer. Ultrasounds use high-frequency sound waves to create pictures of internal organs and tissues. ABUS has been found to be equal to HHUS for whole breast screening, but no data exist on its use for screening of reconstructed patients. This clinical trial evaluates the feasibility of using ABUS versus HHUS to screen women who have undergone reconstruction.

Conditions

Malignant Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• Detection of the residual tissue (i.e., artifact) in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients by automated breast ultrasound (ABUS) and handheld ultrasound (HHUS)

  This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test.

  Up to 1 year

Study Arms (1)

Screening (automated breast ultrasound, handheld ultrasound)

EXPERIMENTAL

Participants undergo HHUS and ABUS in no required order over 1 hour.

Procedure: Ultrasonography; Procedure: Automated Breast Ultrasound

Interventions

Ultrasonography PROCEDURE

Undergo HHUS

Screening (automated breast ultrasound, handheld ultrasound)

Automated Breast Ultrasound PROCEDURE

Undergo ABUS

Also known as: ABUS

Screening (automated breast ultrasound, handheld ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• \>= 18 years of age at time of consent
• Free of focal breast symptoms and with no suspicious breast physical exam findings
• Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital
• Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign
• Willing to comply with all study procedures and be available for the duration of the study
• Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound

You may not qualify if:

• History of breast cancer recurrence
• Current focal breast symptoms since NSM or SSM with reconstruction
• NSM or SSM with reconstruction was performed years prior to study enrollment
• Bilateral NSM or SSM with reconstruction
• Females who are pregnant

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: November 18, 2022
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)