DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
- Conditions
- Breast Cancer
- Interventions
- Procedure: diffusion-weighted magnetic resonance imaging
- Registration Number
- NCT01564368
- Lead Sponsor
- American College of Radiology Imaging Network
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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).
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 406
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diffusion Weighted-MRI diffusion-weighted magnetic resonance imaging 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.
- Primary Outcome Measures
Name Time Method Pathologic Complete Response (pCR) Surgery Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer.
ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system
- Secondary Outcome Measures
Name Time Method Within-subject Coefficient of Variation (wCV) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment) within-subject standard deviation (wSD) Within-subject coefficient of variation (wCV): \[wCV = 100%\*wSD/mean\]
Smaller values of wCV bounded for \[0,...) represent better agreementRepeatability Coefficient (RC)Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment) within-subject standard deviation (wSD) Repeatability coefficient (RC): \[RC = 2.77\*wSD\] (units: 10E-3 mm/sec\^2)
Smaller values of RC, bounded \[0, ...), represent agreementAgreement Index (AI) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment) Test and retest DWI measurements for a given patient were performed on the same day in a single imaging session.
Agreement index (AI): (Zhang, Wang, Duan - 2014) is based on the data's overall ranking. AI confidence intervals were obtained via bootstrap method Larger values AI (bounded \[0.5,1\]) represent agreementFunctional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR) Surgery Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer.
ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system Functional tumor volume (FTV) (units cm3) was computed by summing all tumor voxels meeting specific enhancement criteria, with customized thresholds for each site to account for variability in MR imaging systemsICC Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment) Test and retest DWI measurements for a given patient were performed on the same day in a single imaging session.
Intraclass correlation coefficient (ICC) is derived from the analysis of variance (ANOVA) model estimates (Barnhart,Haber, Lin 2007),
Larger values of ICC (bounded \[-1,1\]) represent agreementDetermine the Accuracy of Predictive Models Including Covariates for Combined Measurement of Change in Tumor ADC Value, Change in Tumor Volume, and Other Variables baseline and mid-treatment Accuracy will be measured as the Area under the Receiver Operating Characteristic Curve (AUC) Predictive logistic regression modeling was performed in 207 patients with complete mid-treatment ΔADC and ΔFTV data.
To build prediction models with ADC and other variables, a data-splitting approach was used where a randomly selected 60% of participants (124 patients), stratified according to pCR status and tumor subtype, were selected as the training data set and the rest (86 patients) as the test set. Logistic regression with backward variable selection was used to construct the prediction models, which were then applied to the remaining 40% of the data to obtain predictive scores for each participant.
Trial Locations
- Locations (7)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington/SCCA
🇺🇸Seattle, Washington, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States