NCT05704062 Quantitative MRI Assessment of Breast Cancer Therapy Response
| NCT ID | NCT05704062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corewell Health East |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 135 participants |
| Start Date | 2010-03-18 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 135 participants in total. It began in 2010-03-18 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Wei Huang, Ph.D.
PRINCIPAL INVESTIGATOR
Corewell Health William Beaumont University Hoospital
Frequently Asked Questions
Who can join the NCT05704062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05704062 currently recruiting?
Yes, NCT05704062 is actively recruiting participants. Contact the research team at wei.huang@corewellhealth.org for enrollment information.
Where is the NCT05704062 trial being conducted?
This trial is being conducted at Iowa City, United States, Royal Oak, United States, Portland, United States, Seattle, United States.
Who is sponsoring the NCT05704062 clinical trial?
NCT05704062 is sponsored by Corewell Health East. The principal investigator is Wei Huang, Ph.D. at Corewell Health William Beaumont University Hoospital. The trial plans to enroll 135 participants.
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