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)
- 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
- 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
Primary Purpose: Diagnostic
Pathologic complete response (pCR)
Nola M. Hylton, PhD
University of California, San Francisco