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

NCT ID: NCT02488187

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ABUS vs MRI (ultrasound when indicated)

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.

Group Type: OTHER

ABUS

Intervention Type: DEVICE

Automated breast ultrasound

ABUS vs mammography (ultrasound when indicated)

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.

Group Type: OTHER

ABUS

Intervention Type: DEVICE

Automated breast ultrasound

Interventions

ABUS

Automated breast ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Kansas Cancer Center

Westwood, Kansas, United States

Countries

United States

Other Identifiers

ABUS

Identifier Type: -

Identifier Source: org_study_id