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

This study is currently recruiting participants.
Verified August 2013 by American College of Radiology Imaging Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01564368
First received: March 24, 2012
Last updated: August 19, 2013
Last verified: August 2013

March 24, 2012
August 19, 2013
August 2012
February 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Pathologic complete response (pCR) [ 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01564368 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in ADC value, DCE-MRI tumor volume, and SER [ Designated as safety issue: No ]
  • Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER [ Designated as safety issue: No ]
  • Test-retest reproducibility of DW-MRI ADC metric [ Designated as safety issue: No ]
Not Provided
Not Provided
 
DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
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)

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Procedure: diffusion-weighted magnetic resonance imaging
Other Names:
  • functional MRI
  • DWI
  • diffusion-weighted MRI
  • DW-MRI
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.
Intervention: Procedure: diffusion-weighted magnetic resonance imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
304
Not Provided
February 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Not Provided
United States
 
NCT01564368
CDR0000729174, ACRIN-6698, CA80098
Yes
American College of Radiology Imaging Network
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Principal Investigator: Nola M. Hylton, PhD University of California, San Francisco
American College of Radiology Imaging Network
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP