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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of Automated Breast Ultrasound (ABUS) Versus Handheld Ultrasound (HHUS) for Breast Cancer Surveillance in Women With Nipple Sparing or Skin Sparing Mastectomy With Reconstruction

Conditions
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Malignant Breast Neoplasm

Intervention / Treatment
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* Procedure: Ultrasonography
* Procedure: Automated Breast Ultrasound


Participation Criteria
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Eligibility Criteria
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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 within the last five years 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 > 5 years prior to study enrollment Bilateral NSM or SSM with reconstruction Females who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (automated breast ultrasound, handheld ultrasound)<br>Participants undergo HHUS and ABUS in no required order over 1 hour. | Procedure: Ultrasonography<br>* Undergo HHUS<br>Procedure: Automated Breast Ultrasound<br>* Undergo ABUS<br>* Other names: ABUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |