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DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer (ACRIN6702)

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ClinicalTrials.gov Identifier: NCT02022579
Recruitment Status : Unknown
Verified October 2018 by American College of Radiology Imaging Network.
Recruitment status was:  Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
American College of Radiology Imaging Network

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer BIRADS 3 BIRADS 4 BIRADS 5 Procedure: DCE-MRI and DWI Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Apparent Diffusion Coefficient (ADC) [ Time Frame: 1 year ]
    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 :
  1. Optimal ADC Cutoffs by Lesion Type [ Time Frame: 1 year ]
    Whether optimal ADC cutoffs are different for mass and non-mass lesion types;

  2. Local and Central Review Comparison (ADC Value Differences) [ Time Frame: 1 year ]
    Whether site-generated ADC values differ significantly from those obtained by central review;

  3. Minimum B-Value for Differentiating Lesions [ Time Frame: 1 year ]
    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;

  4. ADC Measurements/Ratios to Define Subject Lesion Variations [ Time Frame: 1 year ]
    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;

  5. Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC) [ Time Frame: 1 year ]
    Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022579


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Investigators
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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
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT02022579    
Other Study ID Numbers: ACRIN 6702
U01CA080098 ( U.S. NIH Grant/Contract )
U01CA079778 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
Keywords provided by American College of Radiology Imaging Network:
Breast Cancer
Diagnosis
Malignant
Benign
Biopsy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases