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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)


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Pathologic complete response (pCR)

Safety Issue:

No

Principal Investigator

Nola M. Hylton, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

Unspecified

Study ID:

CDR0000729174

NCT ID:

NCT01564368

Start Date:

August 2012

Completion Date:

Related 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

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