Assessing breast cancer treatment response using MRI
Functional Magnetic Resonance Imaging Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy
This study is testing if advanced MRI techniques can better show how breast cancer responds to chemotherapy compared to regular size measurements, helping doctors predict treatment success.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corewell Health East Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Iowa City, Iowa and 3 other locations) |
| Trial ID | NCT05704062 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with confirmed breast cancer who are scheduled to receive neoadjuvant chemotherapy and meet specific MRI eligibility criteria.
Not a fit: Patients with conditions that contraindicate MRI or those unable to undergo the procedure due to severe claustrophobia or other medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely assessments of breast cancer treatment responses, improving patient management and outcomes.
How similar studies have performed: Other studies have shown promise in using MRI for assessing treatment responses in breast cancer, but this approach aims to validate and expand upon those findings across different MRI platforms.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Iowa City, Iowa and 3 other locations
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (Recruiting)
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Completed)
- University of Washington — Seattle, Washington, United States (Recruiting)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.