Clinical trial NCT01564368: DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-27
Enrollment: 406
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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

Primary outcomes:
measure: Pathologic Complete Response (pCR)
timeFrame: Surgery
Secondary outcomes:
measure: Functional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR)
timeFrame: Surgery
measure: Determine the Accuracy of Predictive Models Including Covariates for Combined Measurement of Change in Tumor ADC Value, Change in Tumor Volume, and Other Variables
timeFrame: baseline and mid-treatment
measure: Repeatability Coefficient (RC)Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors
timeFrame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)
measure: Within-subject Coefficient of Variation (wCV) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors
timeFrame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)
measure: ICC Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors
timeFrame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)
measure: Agreement Index (AI) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors
timeFrame: baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington/SCCA
state: Washington
Study officials:
affiliation: University of California, San Francisco
name: Nola M. Hylton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
citation: Li W, Partridge SC, Newitt DC, Steingrimsson J, Marques HS, Bolan PJ, Hirano M, Bearce BA, Kalpathy-Cramer J, Boss MA, Teng X, Zhang J, Cai J, Kontos D, Cohen EA, Mankowski WC, Liu M, Ha R, Pellicer-Valero OJ, Maier-Hein K, Rabinovici-Cohen S, Tlusty T, Ozery-Flato M, Parekh VS, Jacobs MA, Yan R, Sung K, Kazerouni AS, DiCarlo JC, Yankeelov TE, Chenevert TL, Hylton NM. Breast Multiparametric MRI for Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer: The BMMR2 Challenge. Radiol Imaging Cancer. 2024 Jan;6(1):e230033. doi: 10.1148/rycan.230033.
citation: Partridge SC, Zhang Z, Newitt DC, Gibbs JE, Chenevert TL, Rosen MA, Bolan PJ, Marques HS, Romanoff J, Cimino L, Joe BN, Umphrey HR, Ojeda-Fournier H, Dogan B, Oh K, Abe H, Drukteinis JS, Esserman LJ, Hylton NM; ACRIN 6698 Trial Team and I-SPY 2 Trial Investigators. Diffusion-weighted MRI Findings Predict Pathologic Response in Neoadjuvant Treatment of Breast Cancer: The ACRIN 6698 Multicenter Trial. Radiology. 2018 Dec;289(3):618-627. doi: 10.1148/radiol.2018180273. Epub 2018 Sep 4.
citation: Newitt DC, Amouzandeh G, Partridge SC, Marques HS, Herman BA, Ross BD, Hylton NM, Chenevert TL, Malyarenko DI. Repeatability and Reproducibility of ADC Histogram Metrics from the ACRIN 6698 Breast Cancer Therapy Response Trial. Tomography. 2020 Jun;6(2):177-185. doi: 10.18383/j.tom.2020.00008.
citation: Newitt DC, Zhang Z, Gibbs JE, Partridge SC, Chenevert TL, Rosen MA, Bolan PJ, Marques HS, Aliu S, Li W, Cimino L, Joe BN, Umphrey H, Ojeda-Fournier H, Dogan B, Oh K, Abe H, Drukteinis J, Esserman LJ, Hylton NM; ACRIN Trial Team and I-SPY 2 TRIAL Investigators. Test-retest repeatability and reproducibility of ADC measures by breast DWI: Results from the ACRIN 6698 trial. J Magn Reson Imaging. 2019 Jun;49(6):1617-1628. doi: 10.1002/jmri.26539. Epub 2018 Oct 22.
citation: Partridge SC, Steingrimsson J, Newitt DC, Gibbs JE, Marques HS, Bolan PJ, Boss MA, Chenevert TL, Rosen MA, Hylton NM. Impact of Alternate b-Value Combinations and Metrics on the Predictive Performance and Repeatability of Diffusion-Weighted MRI in Breast Cancer Treatment: Results from the ECOG-ACRIN A6698 Trial. Tomography. 2022 Mar 4;8(2):701-717. doi: 10.3390/tomography8020058.
citation: Newitt DC, Tan ET, Wilmes LJ, Chenevert TL, Kornak J, Marinelli L, Hylton N. Gradient nonlinearity correction to improve apparent diffusion coefficient accuracy and standardization in the american college of radiology imaging network 6698 breast cancer trial. J Magn Reson Imaging. 2015 Oct;42(4):908-19. doi: 10.1002/jmri.24883. Epub 2015 Mar 11.