DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/13/2018 |
Start Date: | August 2012 |
End Date: | December 2018 |
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)
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.
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.
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.
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.
DISEASE CHARACTERISTICS:
- 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
We found this trial at
7
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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