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

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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.

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.

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
1515 Holcombe Blvd
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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Houston, TX
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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3181 Southwest Sam Jackson Park Road
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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Portland, OR
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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San Francisco, California 94143
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San Francisco, CA
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Seattle, Washington
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Seattle, WA
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