Automated Breast Ultrasound or MRI in Detecting Additional Breast Cancer Sites before Surgery in Patients Newly Diagnosed with Breast Cancer
This trial is active, not recruiting.
|Sponsor||University of Kansas Medical Center|
|Start date||April 2013|
|End date||July 2016|
|Trial size||115 participants|
|Trial identifier||NCT02488187, ABUS|
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|
|Intervention model||parallel assignment|
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
time frame: 1 day
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
|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.|
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