Quantitative MRI Assessment of Breast Cancer Therapy Response

NCT05704062 | Recruiting

• 4 other identifiers: 2025-000R01CA248192NCI-2020-05192IRB00005492
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this observational study is to investigate and validate multi-parametric magnetic resonance imaging (MRI) modalities for assessment of breast cancer response to neoadjuvant chemotherapy in a multi-site and multi-MRI scanner platform setting. This study is conducted at Oregon Health \& Science University (OHSU), University of Washington (UW), and University of Iowa (UI) using Siemens, Philips, and General Electric MRI scanners, respectively. MRI is a type of scan that uses a very strong magnet and no radiation to take very detailed pictures of parts of the body. MRI is often used as standard of care to take pictures of breast tumor(s) before and after chemotherapy treatment in order to measure the tumor size changes in response to treatment, and in order to plan for surgery. MRI is used because the images it takes are very clear and the borders of the tumor can be measured very accurately. However the tumor size alone is often not a good early indicator of whether or not the tumor responds to treatment. Tumor size change usually happens late during the period of treatment, and tumor size measured with MRI after treatment can overestimate or underestimate the residual cancer. This makes it difficult to do the right surgical planning. In addition to measuring tumor size, the MRI scans in this research study will also measure changes in tumor blood vessels and the number of cancer cells per unit of tumor volume. The purpose of this study is to see whether MRI measurements of these functional tumor properties provide better early prediction and evaluation of breast cancer response to neoadjuvant chemotherapy than tumor size measurement. This is an observational study because the MRI procedures are not expected to have an effect on health outcomes. Eligible participants on this study are receiving standard of care neoadjuvant treatment for their cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy

  Functional MRI biomarkers, Kᵗʳᵃⁿˢ (transfer rate constant in min-¹), vₑ (extravascular and extracellular space volume fraction), kₑₚ (efflux rate constant in min-¹), and τᵢ (mean intracellular water lifetime in sec) along with ADC (apparent diffusion coefficient in mm²/sec) will be obtained from DCE- and DW-MRI. Tumor longest diameter (LD) will be measured (in mm). Early changes (%) in each MRI parameter will be derived and correlated with pathologic response status, pathologic complete response (pCR) or non-pCR, obtained from the resected tumor. Predictive accuracy for pCR vs. non-pCR is determined by area under the receiver operating characteristic curve (ROC AUC) for each parameter change (%). Comparison of AUC will determine if change (%) of a functional MRI biomarker is more accurate than LD in prediction of pCR vs. non-pCR. Also, changes (%) of all functional biomarkers will be combined using multivariate logistic regression and compared with that of LD for predictive accuracy.

  Through study completion, up to 5 years

Secondary Outcomes (3)

• Compare functional MRI biomarkers with tumor size measurement for assessment of residual cancer burden

  Through study completion, up to 5 years

• Compare functional MRI biomarkers with tumor size measurement for prognosis of recurrence-free survival

  Up to 5 years after study completion

• Validation of Shutter-Speed dynamic contrast-enhanced (DCE) MRI as a robust method for prediction and evaluation of breast cancer response to neoadjuvant chemotherapy

  Through study completion, up to 5 years

Study Arms (1)

Diagnostic (multi-parametric MRI)

Patients undergo an MRI exam that includes standard anatomic scans, DCE-MRI, and DW-MRI at baseline, after first treatment cycle, at mid-point of treatment course, and after completion of neoadjuvant chemotherapy.

Procedure: Diffusion Weighted Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Interventions

Diffusion Weighted Imaging PROCEDURE

Undergo DW-MRI

Also known as: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DW-MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging

Diagnostic (multi-parametric MRI)

Dynamic Contrast-Enhanced Magnetic Resonance Imaging PROCEDURE

Undergo DCE-MRI

Also known as: DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

Diagnostic (multi-parametric MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer who are scheduled to receive standard of care neoadjuvant chemotherapy prior to surgery.

You may qualify if:

• Patients with histologically confirmed breast cancer who are scheduled to receive standard of care neoadjuvant chemotherapy prior to surgical management
• No contraindication for an MRI exam
• Normal kidney functional for receiving a standard dose of gadolinium-based MRI contrast agent through IV injection
• Not pregnant
• Ability to understand and the willingness to sign a written informed consent document. A signed study-specific informed consent must be obtained prior to any study specific procedures

You may not qualify if:

• Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip, or any other condition that would warrant avoidance of a strong magnetic field
• Patients who are unable to cooperate for an MRI exam lasting about 45 min, and/or have known allergic reaction to gadolinium-based contrast agent
• Severe claustrophobia precluding subject from undergoing MRI
• Patients with acute or chronic kidney dysfunction (estimated glomerular filtration rate \[eGFR\] \< 60 ml/min/1.73 m\^2 as calculated using the Modification of Diet in Renal Disease \[MDRD\] equation)
• Pregnant participants are excluded from this study because it is difficult for them to lie prone on the MRI table and because of possible risk to the fetus
• Cognitively impaired

Sponsors & Collaborators

• Corewell Health East: lead
• National Cancer Institute (NCI): collaborator
• University of Washington: collaborator
• University of Iowa: collaborator
• Oregon Health and Science University: collaborator

Study Sites (4)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

COMPLETED

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei Huang, Ph.D.

  Corewell Health William Beaumont University Hoospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Huang, Chief, MR Rad Imaging Physics, PhD

CONTACT

248-551-6468; wei.huang@corewellhealth.org

Kristen Grant, RN

CONTACT

248-551-0439

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 30, 2023
• Study Start: March 18, 2010
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-01

Locations

US (4)