DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy (ACRIN 6698)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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) [ Time Frame: Until surgery ] [ 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 [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
- Changes in ADC value, DCE-MRI tumor volume, and SER [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
- Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
- Test-retest reproducibility of DW-MRI ADC metric [ Time Frame: Pre-treatment MRI ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Diffusion Weighted-MRI
Participants on all arms of the I-SPY II trial will undergo DW=MRI 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564368
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States|
|Contact: Heidi R Umphrey, PhD 205-996-4132 firstname.lastname@example.org|
|Contact: Haley Witte 205-996-9973 email@example.com|
|Principal Investigator: Heidi R. Umphrey, PhD|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States|
|Contact: Nola Hylton, PhD 415-885-7511 firstname.lastname@example.org|
|Contact: Margarita Watkins 415-476-0734 email@example.com|
|Principal Investigator: Nola Hylton, PhD|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States|
|Contact: Patrick Bolan, PhD 612-625-6526 firstname.lastname@example.org|
|Contact: Karen Kowalick 612-626-6087 email@example.com|
|Principal Investigator: Patrick Bolan, PhD|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States|
|Contact: Karen Oh, PhD 503-494-4511 firstname.lastname@example.org|
|Contact: Amy Wilson 503.418.9736 email@example.com|
|Principal Investigator: Karen Oh, PhD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States|
|Contact: Mark Rosen, MD, PhD 215-662-3107 Mark.Rosen@uphs.upenn.edu|
|Contact: Kathleen Thomas 215-746-0352 Kathleen.Thomas@uphs.upenn.edu|
|Principal Investigator: Mark Rosen, MD, PhD|
|United States, Texas|
|University of Texas M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States|
|Contact: Basak E. Dogan, MD 713-563-0124 firstname.lastname@example.org|
|Contact: Jie Zhang 713-563-0735 email@example.com|
|Principal Investigator: Basak E. Dogan, PhD|
|United States, Washington|
|University of Washington/SCCA||Recruiting|
|Seattle, Washington, United States|
|Contact: Savannah Partridge, PhD 206-288-1306 firstname.lastname@example.org|
|Contact: Megan Miller 206-288-6537 email@example.com|
|Principal Investigator: Savannah Partridge, PhD|
|Principal Investigator:||Nola M. Hylton, PhD||University of California, San Francisco|