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DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy (ACRIN 6698)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by American College of Radiology Imaging Network.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01564368
First received: March 24, 2012
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: diffusion-weighted magnetic resonance imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • Pathologic complete response (pCR) [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
  • Change in ADC value as measured by area under the receiver operating characteristic curve from each treatment timepoint to baseline [ Time Frame: Until surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in ADC value, DCE-MRI tumor volume, and SER [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
  • Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
  • Test-retest reproducibility of DW-MRI ADC metric [ Time Frame: Pre-treatment MRI ] [ Designated as safety issue: No ]

Estimated Enrollment: 304
Study Start Date: August 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diffusion Weighted-MRI
Participants on all arms of the I-SPY II trial will undergo DW=MRI as described in the ACRIN 6698 protocol. The experimental component/intervention is whether DW-MRI can predict therapeutic response in neoadjuvant treatment for breast cancer.
Procedure: diffusion-weighted magnetic resonance imaging
Other Names:
  • functional MRI
  • DWI
  • diffusion-weighted MRI
  • DW-MRI

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564368

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, California
University of California, San Francisco
San Francisco, California, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
United States, Washington
University of Washington/SCCA
Seattle, Washington, United States
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nola M. Hylton, PhD University of California, San Francisco
  More Information

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01564368     History of Changes
Other Study ID Numbers: CDR0000729174  ACRIN-6698  CA80098 
Study First Received: March 24, 2012
Last Updated: May 1, 2014
Health Authority: United States: NCI

Keywords provided by American College of Radiology Imaging Network:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on December 08, 2016