Breast Cancer Clinical Trial

DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

406

Study ID:

NCT01564368

Recruitment Status:

Completed

Sponsor:

American College of Radiology Imaging Network

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There are 7 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
University of California, San Francisco
San Francisco California, 94143, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
University of Washington/SCCA
Seattle Washington, 98195, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

406

Study ID:

NCT01564368

Recruitment Status:

Completed

Sponsor:


American College of Radiology Imaging Network

How clear is this clinincal trial information?

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