Assessing breast cancer treatment response using MRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate multi-parametric MRI techniques for evaluating how breast cancer responds to neoadjuvant chemotherapy across multiple sites and MRI scanner platforms. Conducted at Oregon Health & Science University, University of Washington, and University of Iowa, the study will utilize various MRI modalities, including dynamic contrast-enhanced and diffusion-weighted imaging, to measure tumor changes before and after treatment. The primary objective is to determine if functional MRI biomarkers can predict treatment response more accurately than traditional tumor size measurements. The study will also assess the effectiveness of these imaging techniques in predicting long-term outcomes based on pathological analyses of surgical specimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting
• Corewell Health William Beaumont University Hospital
  Royal Oak, Michigan, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting
• OHSU Knight Cancer Institute
  Portland, Oregon, United States Completed

Study contacts

• Principal investigator: Wei Huang, Ph.D. — Corewell Health William Beaumont University Hoospital
• Study coordinator: Wei Huang, Chief, MR Rad Imaging Physics, PhD
• Email: wei.huang@corewellhealth.org
• Phone: 248-551-6468

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.