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

University of Kansas Medical Center115 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

115

Conditions

Breast Cancer

Interventions

ABUSDEVICE

Automated breast ultrasound

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Cancer Center

Westwood, Kansas, United States

Outcomes

Primary Outcomes

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).

Time frame: 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.