Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients

Study Overview
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Brief Summary
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Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.

Detailed Description
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This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.

Official Title
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Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: ABUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy. Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS. If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1). If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2). The MRI and ABUS exam must be obtained within 2 weeks of each other. Exclusion Criteria: Males Pregnant women Lactating women Patients < 18 and > 100 years of age Patients with breast implants

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ABUS vs MRI (ultrasound when indicated)<br>To compare the overall sensitivity and specificity of ABUS versus MRI (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients. | Device: ABUS<br>* Automated breast ultrasound<br>|
| Other: ABUS vs mammography (ultrasound when indicated)<br>To compare the sensitivity and specificity of ABUS versus mammography (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients when MRI is not performed. | Device: ABUS<br>* Automated breast ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging | Rate of detection of occult breast cancer by ABUS, otherwise missed by standard imaging (MRI or mammogram with hand-held breast ultrasound as clinically indicated). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, MRI, Mammogram, Whole Breast Sonogram, ABUS