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)
Only sites participating in the I-SPY 2 TRIAL consortium may participate in the ACRIN 6698 study.
Protocol-ACRIN 6698, 2.29.12 [PDF]
Informed Consent-ACRIN 6698, 2.29.12 [DOC]
Protocol Principal Investigators:
Nola Hylton, PhD
Savannah Partridge, PhD
Mark Rosen, MD, PhD
Thomas Chenevert, PhD
Overview: The objective of ACRIN 6698 study is to determine if diffusion weighted magnetic resonance imaging (DW-MRI) is effective for measuring breast tumor response to neoadjuvant treatment and if response measured by DWI early in the course of taxane-based therapy is predictive of pathologic response. ACRIN 6698 will be performed as a sub-study to the ongoing I-SPY 2 breast cancer neoadjuvant treatment trial.
Main Objectives: This trial's primary aim is to determine if the change in tumor apparent diffusion coefficient (ADC) value measured from each treatment timepoint to baseline using diffusion-weighted MRI (DW-MRI) is predictive of pathologic complete response. Secondary aims include: Determining 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 pathologic complete response (pCR); investigating the relative effectiveness of the individual measurements, change in tumor ADC value, change in tumor volume, and change in peak signal enhancement ratio (SER) for predicting pathologic complete response in experimental treatment arms; and assessing the test-retest reproducibility of ADC measurements by DW-MRI applied to breast tumors.
Participants: Women who are eligible to participate in the I-SPY 2 TRIAL may co-enroll in the ACRIN 6698 imaging study.
Study Design: I-SPY 2 protocol includes four DCE-MRI scans as a measurement method for tumor response. In the current I-SPY 2 TRIAL, change in tumor volume, measured at multiple time points during treatment, will be used to update the patient randomization schema as the trial progresses. ACRIN 6698 contains advanced DWI acquisition parameters which will be included as part of the I-SPY 2 MRI examinations. ACRIN 6698 protocol will address the question of DWI sensitivity to drug effects via alterations in tumor water mobility, and will directly compare DWI-MRI to dynamic contrast-enhanced MRI (DCE-MRI) measurements of tumor microvascular behavior. The ACRIN 6698 imaging protocol will include the necessary elements for a high quality, quantitative imaging study, including protocol specifications, monitoring and quality control, image processing, and contextual data analysis.