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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABUS
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, MRI, Mammogram, Whole Breast Sonogram, ABUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Kansas Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ABUS vs MRI (ultrasound when indicated)

ABUS vs mammography (ultrasound when indicated)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 30, 2015
Last Updated
January 18, 2017
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02488187
Brief Title
Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients
Acronym
ABUS
Official Title
Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, MRI, Mammogram, Whole Breast Sonogram, ABUS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABUS vs MRI (ultrasound when indicated)
Arm Type
Other
Arm Description
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.
Arm Title
ABUS vs mammography (ultrasound when indicated)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ABUS
Intervention Description
Automated breast ultrasound
Primary Outcome Measure Information:
Title
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
Description
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).
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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