RecruitingNCT05704062

Quantitative MRI Assessment of Breast Cancer Therapy Response

Functional Magnetic Resonance Imaging Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy


Sponsor

Corewell Health East

Enrollment

135 participants

Start Date

Mar 18, 2010

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using advanced MRI techniques to measure how well breast cancer is responding to chemotherapy before surgery (neoadjuvant chemotherapy). The goal is to develop better imaging tools that can predict treatment response earlier, potentially helping tailor treatment to each patient. **You may be eligible if...** - You have been diagnosed with breast cancer confirmed by biopsy - You are scheduled to receive chemotherapy before surgery (neoadjuvant treatment) - Your kidneys are functioning well enough for MRI contrast dye - You are not pregnant - You are willing to sign an informed consent form **You may NOT be eligible if...** - You have a pacemaker, aneurysm clip, or other metal implant that prevents MRI - You are allergic to MRI contrast dye (gadolinium) - You have severe claustrophobia - You have kidney disease (eGFR below 60) - You are pregnant - You have cognitive impairment that prevents participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDiffusion Weighted Imaging

Undergo DW-MRI

PROCEDUREDynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE-MRI


Locations(4)

University of Iowa

Iowa City, Iowa, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

University of Washington

Seattle, Washington, United States

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NCT05704062


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