DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy (ACRIN6698)
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| ClinicalTrials.gov Identifier: NCT01564368 |
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Recruitment Status :
Completed
First Posted : March 27, 2012
Results First Posted : February 10, 2023
Last Update Posted : April 15, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Procedure: diffusion-weighted magnetic resonance imaging | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 406 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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) |
| Actual Study Start Date : | August 27, 2012 |
| Actual Primary Completion Date : | July 19, 2018 |
| Actual Study Completion Date : | January 14, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Diffusion Weighted-MRI
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.
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Procedure: diffusion-weighted magnetic resonance imaging
diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation
Other Names:
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- Pathologic Complete Response (pCR) [ Time Frame: 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) as a Predictor of Pathologic Complete Response (pCR) [ Time Frame: 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 systems
- Determine the Accuracy of Predictive Models Including Covariates for Combined Measurement of Change in Tumor ADC Value, Change in Tumor Volume, and Other Variables [ Time Frame: 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.
- Repeatability Coefficient (RC)Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors [ Time Frame: 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 agreement
- Within-subject Coefficient of Variation (wCV) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors [ Time Frame: 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 agreement
- ICC Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors [ Time Frame: 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 agreement
- Agreement Index (AI) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors [ Time Frame: 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 agreement
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Meets I-SPY 2 TRIAL inclusion criteria
- High-risk for recurrent disease
PATIENT CHARACTERISTICS:
- Able to tolerate imaging required by protocol
PRIOR CONCURRENT THERAPY:
- Not specified
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564368
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| University of Washington/SCCA | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Nola M. Hylton, PhD | University of California, San Francisco |
Documents provided by American College of Radiology Imaging Network:
Publications of Results:
Other Publications:
| Responsible Party: | American College of Radiology Imaging Network |
| ClinicalTrials.gov Identifier: | NCT01564368 |
| Other Study ID Numbers: |
CDR0000729174 ACRIN-6698 ( Other Identifier: NCI CIP ) U01CA080098 ( U.S. NIH Grant/Contract ) U01CA079778 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 27, 2012 Key Record Dates |
| Results First Posted: | February 10, 2023 |
| Last Update Posted: | April 15, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | See ACRIN data sharing Policy https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | 6mo post publication |
| Access Criteria: | upon request |
| URL: | https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx |
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stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
stage IV breast cancer HER2-negative breast cancer HER2-positive breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |