RecruitingRecruiting
Quantitative MRI Assessment of Breast Cancer Therapy Response
NCT05704062 · Corewell Health East
In plain English
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Official title
Functional Magnetic Resonance Imaging Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy
About this study
PRIMARY OBJECTIVE:
I. To investigate, compared to tumor size measurement, if functional MRI biomarkers or combination of a set of functional biomarkers provide earlier prediction of responders vs. non-responders with pathological analyses of surgical specimens as the endpoints.
SECONDARY OBJECTIVES:
I. To investigate, compared to tumor size measurement, which MRI functional biomarker or combination of a set of biomarkers provides:
Ia. A more accurate assessment of residual cancer burden with pathological analyses of surgical specimens as the endpoints.
Ib. A more accurate prognosis of five-year recurrence-free survival.
II. To validate that the Shutter-Speed dynamic contrast-enhanced (DCE) MRI method, which measures tumor blood flow and vessel wall leakiness, as well as tumor metabolic activity, and was developed by OHSU investigators on the Siemens scanner platform, is a robust method for prediction and evaluation of breast cancer response to neoadjuvant chemotherapy across major MRI scanner platforms (Siemens, Philips, and General Electric).
OUTLINE:
Patients undergo dynamic contrast-enhanced (DCE)-MRI (for measuring tumor blood vessel changes) and diffusion-weighted (DW)-MRI (for measuring tumor cell density changes) together with some standard anatomic MRI scans for about 45 minutes at baseline, after first treatment cycle, at mid-point of treatment course, and after completion of neoadjuvant chemotherapy.
Eligibility 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
Study design
Enrollment target: 135 participants
Age groups: adult, older_adult
Timeline
Starts: 2010-03-18
Estimated completion: 2027-05-31
Last updated: 2026-04-17
Interventions
Procedure: Diffusion Weighted ImagingProcedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Primary outcomes
- • Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy (Through study completion, up to 5 years)
Sponsor
Corewell Health East · other
With: National Cancer Institute (NCI), University of Washington, University of Iowa, Oregon Health and Science University
Contacts & investigators
ContactWei Huang, Chief, MR Rad Imaging Physics, PhD · contact · wei.huang@corewellhealth.org · 248-551-6468
ContactKristen Grant, RN · contact · 248-551-0439
InvestigatorWei Huang, Ph.D. · principal_investigator, Corewell Health William Beaumont University Hoospital
All locations (4)
University of IowaRecruiting
Iowa City, Iowa, United States
Corewell Health William Beaumont University HospitalRecruiting
Royal Oak, Michigan, United States
OHSU Knight Cancer InstituteCompleted
Portland, Oregon, United States
University of WashingtonRecruiting
Seattle, Washington, United States