DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy (ACRIN6698)
|ClinicalTrials.gov Identifier: NCT01564368|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2012
Last Update Posted : March 20, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: diffusion-weighted magnetic resonance imaging|
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||304 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: Diffusion Weighted-MRI
Participants on all arms of the I-SPY II trial will undergo diffusion-weighted magnetic resonance imaging as described in the ACRIN 6698 protocol. The experimental component/intervention is whether DW-MRI can predict therapeutic response in neoadjuvant treatment for breast cancer.
Procedure: diffusion-weighted magnetic resonance imaging
diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation
- Pathologic complete response (pCR) [ Time Frame: Until surgery ]
- Change in ADC value as measured by area under the receiver operating characteristic curve from each treatment timepoint to baseline [ Time Frame: Until surgery ]
- Changes in ADC value, DCE-MRI tumor volume, and SER [ Time Frame: Until surgery ]
- Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER [ Time Frame: Until surgery ]
- Test-retest reproducibility of DW-MRI ADC metric [ Time Frame: Pre-treatment MRI ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564368
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|University of Washington/SCCA|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Nola M. Hylton, PhD||University of California, San Francisco|