NCT01564368CompletedNot Applicable
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)
American College of Radiology Imaging Network14 sites in 1 country406 target enrollmentStarted: August 27, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 406
- Locations
- 14
- Primary Endpoint
- Pathologic Complete Response (pCR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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))
- Repeatability 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))
- Agreement 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))
- Functional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR)(Surgery)
- ICC 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))
- Determine 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)
Investigators
Study Sites (14)
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