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DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy (ACRIN6698)

This study is ongoing, but not recruiting participants.
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: March 16, 2017
Last verified: March 2017
March 24, 2012
March 16, 2017
August 2012
July 2017   (Final data collection date for primary outcome measure)
  • Pathologic complete response (pCR) [ Time Frame: Until surgery ]
  • Change in ADC value as measured by area under the receiver operating characteristic curve from each treatment timepoint to baseline [ Time Frame: Until surgery ]
  • Pathologic complete response (pCR)
  • Change in ADC value as measured by area under the receiver operating characteristic curve from each treatment timepoint to baseline
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 ]
  • Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER [ Time Frame: Until surgery ]
  • Test-retest reproducibility of DW-MRI ADC metric [ Time Frame: Pre-treatment MRI ]
  • Changes in ADC value, DCE-MRI tumor volume, and SER
  • Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER
  • Test-retest reproducibility of DW-MRI ADC metric
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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Breast Cancer
Procedure: diffusion-weighted magnetic resonance imaging
diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation
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 diffusion-weighted magnetic resonance imaging 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.
 
Active, not recruiting
304
March 2018
July 2017   (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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01564368
CDR0000729174
ACRIN-6698 ( Other Identifier: NCI CIP )
U01CA080098 ( US NIH Grant/Contract Award Number )
U01CA079778 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Yes
See ACRIN data sharing Policy https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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
March 2017

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