Back to search results

Observational Study of MRI for Breast Cancer Therapy Response

This observational study is looking at how well different types of MRI scans can predict how breast cancer responds to chemotherapy before surgery. You would undergo Diffusion Weighted Imaging (DW-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI). Researchers want to see if these MRI methods can predict treatment success earlier and more accurately than just measuring tumor size. The study aims to validate a specific DCE-MRI method developed at OHSU across different MRI machines. To join, you must have breast cancer, be scheduled for chemotherapy before surgery, be at least 18 years old, and have no issues with MRI scans or the contrast dye used. The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 135 participants. It is not a randomized trial, meaning participants are not assigned to different treatment groups.
What's involved
You would undergo DW-MRI and DCE-MRI scans. These scans are typically part of standard care before and after chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Researchers will compare MRI results with tumor response through study completion, up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05704062

Quantitative MRI Assessment of Breast Cancer Therapy Response

Recruiting
Not specifiedAges 18+Observational
Corewell Health East
~135 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Diffusion Weighted ImagingDynamic Contrast-Enhanced Magnetic Resonance Imaging

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy
Measured over Through study completion, up to 5 years

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

4 sites across 4 states
Iowa1
Michigan1
Oregon1
Washington1

Study leadership

  • Wei Huang, Ph.D. · PRINCIPAL_INVESTIGATOR · Corewell Health William Beaumont University Hoospital

Who to contact

Wei Huang, Chief, MR Rad Imaging Physics, PhD
[email protected]
248-551-6468
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapyThrough study completion, up to 5 years

    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.