Diffusion-Weighted Magnetic Resonance Imaging in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
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.
Drug: doxorubicin hydrochloride
Other: imaging biomarker analysis
Procedure: breast imaging study
Procedure: diffusion-weighted magnetic resonance imaging
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Primary Purpose: Diagnostic|
|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)|
- Pathologic complete response (pCR) [ Designated as safety issue: No ]
- Change in ADC value as measured by area under the receiver operating characteristic curve from each treatment timepoint to baseline [ Designated as safety issue: No ]
- Changes in ADC value, DCE-MRI tumor volume, and SER [ Designated as safety issue: No ]
- Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER [ Designated as safety issue: No ]
- Test-retest reproducibility of DW-MRI ADC metric [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
- 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.
|Principal Investigator:||Nola M. Hylton, PhD||University of California, San Francisco|