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Summary

Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator
Nola M. Hylton

Description

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.

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)

Details

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.

Keywords

Breast Cancer 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

Eligibility

For females ages 18 years and up

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

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
American College of Radiology Imaging Network
Links
National Cancer Institute's Clinical trial database
ID
NCT01564368
Lead Scientist
Nola M. Hylton
Study Type
Interventional
Last Updated
March 1, 2017