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

NCT ID: NCT05408260

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2025-02-17

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To show that ABUS reduces artifact compared to HHUS in terms of detection of the residual tissue in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients.

SECONDARY OBJECTIVES:

I. To evaluate both the performance and interpretation times for ABUS and HHUS so that these factors can be considered when scheduling patients and for ease of implementation into practice.

II. A short survey will be administered immediately after both ultrasounds performed to enrolled patients to assess their experience with HHUS and ABUS, specifically addressing their perceived comfort level on a numerical scale and if they would be interested in obtaining subsequent annual screening HHUS or ABUS.

EXPLORATORY OBJECTIVE:

I. The appearance of native and reconstructed anatomy on ABUS and HHUS will be studied.

OUTLINE:

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

Participants with ultrasound results indicating Breast Imaging Reporting and Data System (BI-RADS) 4 or 5 (suspicious and needs biopsy) undergo biopsy within 30 days.

Conditions

Malignant Breast Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening (automated breast ultrasound, handheld ultrasound)

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

Group Type: EXPERIMENTAL

Ultrasonography

Intervention Type: PROCEDURE

Undergo HHUS

Automated Breast Ultrasound

Intervention Type: PROCEDURE

Undergo ABUS

Interventions

Ultrasonography

Undergo HHUS

Intervention Type: PROCEDURE

Automated Breast Ultrasound

Undergo ABUS

Intervention Type: PROCEDURE

Other Intervention Names

ABUS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 14405

Identifier Type: OTHER

Identifier Source: secondary_id

19D.799

Identifier Type: -

Identifier Source: org_study_id