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

American College of Radiology Imaging Network

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: diffusion-weighted magnetic resonance imaging

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT01564368

U01CA079778 (U.S. NIH Grant/Contract)

U01CA080098 (U.S. NIH Grant/Contract)

CDR0000729174

ACRIN-6698 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 406 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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406 participants in 1 patient group

Diffusion Weighted-MRI

Experimental group

Description:

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.

Treatment:

Procedure: diffusion-weighted magnetic resonance imaging