Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment abus
Sponsor University of Kansas Medical Center
Start date April 2013
End date July 2016
Trial size 115 participants
Trial identifier NCT02488187, ABUS

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
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.
abus
Automated breast ultrasound
(Other)
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.
abus
Automated breast ultrasound

Primary Outcomes

Measure
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
time frame: 1 day

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.
Location data was received from the National Cancer Institute and was last updated in October 2016.