Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
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 Breast Neoplasms diffusion-weighted magnetic resonance imaging Diffusion Weighted-MRI

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

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Oregon Health and Science University
    Portland Oregon 97239 United States

Lead Scientist

  • Nola M. Hylton
    Nola Hylton, PhD, is a Professor in Residence in the Department of Radiology and Biomedical Imaging, Co-Director of the Breast Cancer Research Interest Group, and Director of the Breast Imaging Research Group at the University of California, San Francisco.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
American College of Radiology Imaging Network
ID
NCT01564368
Study Type
Interventional
Last Updated