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

NCT02488187 | Unknown DMC

• 1 other identifier: ABUS
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer; MRI; Mammogram; Whole Breast Sonogram; ABUS

Outcome Measures

Primary Outcomes (1)

• 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).

  1 day

Study Arms (2)

ABUS vs MRI (ultrasound when indicated)

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.

Device: ABUS

ABUS vs mammography (ultrasound when indicated)

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.

Device: ABUS

Interventions

ABUS DEVICE

Automated breast ultrasound

ABUS vs MRI (ultrasound when indicated); ABUS vs mammography (ultrasound when indicated)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Males
• Pregnant women
• Lactating women
• Patients \< 18 and \> 100 years of age
• Patients with breast implants

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: April 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2016-07

Locations

US (1)