- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02022579
DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer (ACRIN6702)
October 9, 2018 updated by: American College of Radiology Imaging Network
A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer
A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal ADC Cutoffs by Lesion Type
Time Frame: 1 year
|
Whether optimal ADC cutoffs are different for mass and non-mass lesion types;
|
1 year
|
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;
|
1 year
|
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;
|
1 year
|
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;
|
1 year
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
November 1, 2018
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
December 16, 2013
First Submitted That Met QC Criteria
December 23, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Actual)
October 11, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACRIN 6702
- U01CA080098 (U.S. NIH Grant/Contract)
- U01CA079778 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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