Skip to main content
OpenTrials
Completed

NCT Number: NCT01564368

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diffusion-weighted magnetic resonance imaging

Procedure

diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation

Other names: functional MRI, DWI, diffusion-weighted MRI, DW-MRI

Primary outcomes

  1. Pathologic Complete Response (pCR)

    Time frame: Surgery

    Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer.

    ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system

Secondary outcomes

  1. Functional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR)

    Time frame: Surgery

    Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer.

    ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system Functional tumor volume (FTV) (units cm3) was computed by summing all tumor voxels meeting specific enhancement criteria, with customized thresholds for each site to account for variability in MR imaging systems

  2. Determine the Accuracy of Predictive Models Including Covariates for Combined Measurement of Change in Tumor ADC Value, Change in Tumor Volume, and Other Variables

    Time frame: baseline and mid-treatment

    Accuracy will be measured as the Area under the Receiver Operating Characteristic Curve (AUC) Predictive logistic regression modeling was performed in 207 patients with complete mid-treatment ΔADC and ΔFTV data.

    To build prediction models with ADC and other variables, a data-splitting approach was used where a randomly selected 60% of participants (124 patients), stratified according to pCR status and tumor subtype, were selected as the training data set and the rest (86 patients) as the test set. Logistic regression with backward variable selection was used to construct the prediction models, which were then applied to the remaining 40% of the data to obtain predictive scores for each participant.

  3. Repeatability Coefficient (RC)Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors

    Time frame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)

    within-subject standard deviation (wSD) Repeatability coefficient (RC): [RC = 2.77*wSD] (units: 10E-3 mm/sec^2)

    Smaller values of RC, bounded [0, ...), represent agreement

  4. Within-subject Coefficient of Variation (wCV) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors

    Time frame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)

    within-subject standard deviation (wSD) Within-subject coefficient of variation (wCV): [wCV = 100%*wSD/mean]

    Smaller values of wCV bounded for [0,...) represent better agreement

  5. ICC Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors

    Time frame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)

    Test and retest DWI measurements for a given patient were performed on the same day in a single imaging session.

    Intraclass correlation coefficient (ICC) is derived from the analysis of variance (ANOVA) model estimates (Barnhart,Haber, Lin 2007),

    Larger values of ICC (bounded [-1,1]) represent agreement

  6. Agreement Index (AI) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors

    Time frame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)

    Test and retest DWI measurements for a given patient were performed on the same day in a single imaging session.

    Agreement index (AI): (Zhang, Wang, Duan - 2014) is based on the data's overall ranking. AI confidence intervals were obtained via bootstrap method Larger values AI (bounded [0.5,1]) represent agreement

Sponsors and collaborators

Lead sponsor

American College of Radiology Imaging Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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)

Acronym: ACRIN6698

Important dates

Study start
2012
Primary completion
2018
Study completion
2020
First posted
Mar 27, 2012
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.