NCT01564368

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	diffusion-weighted magnetic resonance imaging	diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation

Timeline

• Start date: 2012-08-27
• Primary completion: 2018-07-19
• Completion: 2020-01-14
• First posted: 2012-03-27
• Last updated: 2024-04-15
• Results posted: 2023-02-10

Locations

7 sites across 1 country: United States