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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02488187

Acronym

ABUS

Enrollment

115

Registered

2015-07-02

Start date

2013-04-30

Completion date

2017-12-31

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, MRI, Mammogram, Whole Breast Sonogram, ABUS

Brief summary

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

Detailed description

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.

Interventions

DEVICEABUS

Automated breast ultrasound

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging	1 day	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026