DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by American College of Radiology Imaging Network
Sponsor:
Collaborators:
National Cancer Institutes
ECOG
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT02022579
First received: December 16, 2013
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.


Condition Intervention
Breast Cancer
BIRADS 3
BIRADS 4
BIRADS 5
Procedure: DCE-MRI and DWI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A MULTI-CENTER STUDY EVALUATING THE UTILITY OF DIFFUSION WEIGHTED IMAGING FOR DETECTION AND DIAGNOSIS OF BREAST CANCER

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • Apparent Diffusion Coefficient (ADC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Whether the Apparent Diffusion Coefficient (ADC), when used systematically in conjunction with conventional Dynamic Contrast Enhanced-Magnetic Resonance Imaging (DCE-MRI), can reduce the biopsy rate by at least 20% while maintaining sensitivity.


Secondary Outcome Measures:
  • Optimal ADC Cutoffs by Lesion Type [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Whether optimal ADC cutoffs are different for mass and non-mass lesion types;

  • Local and Central Review Comparison (ADC Value Differences) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Whether site-generated ADC values differ significantly from those obtained by central review;

  • Minimum B-Value for Differentiating Lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Whether the use of a nonzero minimum b-value to reduce perfusion effects in ADC calculation can increase the area under the curve (AUC) for differentiating benign and malignant lesions;

  • ADC Measurements/Ratios to Define Subject Lesion Variations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Whether the use of a normalized ADC measure (tumor/normal ratio) to account for inter- and intra-subject variations in water content and other factors can increase the AUC for differentiating benign and malignant lesions;

  • Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity.


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCE-MRI and DWI
Single arm study, diagnosis defined as BIRADS 3, 4, or 5 lesion(s) based on DCE-MRI only with DWI collected in tandem as standard practice.
Procedure: DCE-MRI and DWI
DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up
Other Names:
  • magnetic resonance imaging
  • MRI
  • DCE-MRI
  • DWI
  • DW-MRI

Detailed Description:

For this study, the investigators plan to evaluate DWI scans performed in women with breast lesions identified by conventional breast MRI. The investigators will determine whether an ADC threshold can be defined for distinguishing benign and malignant lesions on DWI, assess the difference in ADC cutoffs for mass and non-mass lesions, and investigate the potential improvement in accuracy using techniques such as nonzero minimum b-value (to remove perfusion effects in the ADC measures) and normalized ADC measures (to account for variations in water content and other factors).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent;
  • 18 years of age or older;
  • Successful completion of breast MR examination with DWI required by protocol;
  • Undiagnosed breast lesion (BI-RADS 3, 4, or 5) identified on MRI. The BI-RADS assessment must refer to a focal finding within the breast (i.e. mass, non-mass, or focus) as opposed to diffuse processes (e.g. background parenchymal enhancement, skin thickening) or lesions outside the subcutaneous breast (e.g. axillary lymph nodes, focal skin lesions, osseous lesions, etc.).

Exclusion Criteria:

  • Participants with current or recent history (within 6 months prior to the MRI) of chemotherapy for cancer;
  • Neoadjuvant chemotherapy between MRI and confirmation of lesion outcome (study lesions must be biopsied prior to undergoing any chemotherapy);
  • Pregnant (if a female is of childbearing potential - defined as a pre-menopausal female capable of becoming pregnant - confirmation of pregnancy status per the site's standard of practice should be done prior to MRI);
  • Unwilling or not suitable to undergo MRI or use the contrast agent gadolinium.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022579

Contacts
Contact: Savannah Partridge, PhD 206-288-1306 scp3@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Diane Guay    206-598-9322    drguay@uw.edu   
Principal Investigator: Savannah Partridge, PhD         
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institutes
ECOG
Investigators
Principal Investigator: Savannah Partridge, PhD University of Washington
Study Chair: Habib Rahbar, MD University of Washington
Study Chair: Thomas Chenevert, PhD University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT02022579     History of Changes
Other Study ID Numbers: ACRIN 6702
Study First Received: December 16, 2013
Last Updated: February 21, 2014
Health Authority: United States: National Cancer Institutes

Keywords provided by American College of Radiology Imaging Network:
Breast Cancer
Diagnosis
Malignant
Benign
Biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014