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Diffusion Weighted MR Imaging Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: A Sub-study of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And MoLecular Analysis)
RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to treatment. PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in patients with breast cancer undergoing neoadjuvant chemotherapy.
OBJECTIVES: Primary * To determine if the change in tumor apparent diffusion coefficient (ADC) value measured from each treatment timepoint to baseline is predictive of pathologic complete response (pCR). Secondary * To determine if the combined measurement of change in tumor ADC value, change in tumor volume, and change in peak signal-enhancement ratio (SER) is predictive of pCR. * To investigate the relative effectiveness of the individual measurements, change in tumor ADC value, change in tumor volume, and change in peak SER for predicting pCR in experimental treatment arms. * To assess the test-retest reproducibility of ADC metrics applied to breast tumors. OUTLINE: This is a multicenter study. Patients undergo diffusion-weighted magnetic resonance imaging (DWI) at baseline, after week 3 of neoadjuvant paclitaxel regimen, and prior to and after completion of 4 courses of neoadjuvant chemotherapy. Patients then undergo surgery. Patients undergo DWI prior to contrast administration for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). After completion of treatment procedure, patients are followed up for 5 years on the I-SPY 2 TRIAL.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
University of Washington/SCCA
Seattle, Washington, United States
Start Date
August 27, 2012
Primary Completion Date
July 19, 2018
Completion Date
January 14, 2020
Last Updated
April 15, 2024
406
ACTUAL participants
diffusion-weighted magnetic resonance imaging
PROCEDURE
Lead Sponsor
American College of Radiology Imaging Network
Collaborators
NCT04550494
NCT05372640
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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