Breast CancerNCT05704062
Quantitative MRI Assessment of Breast Cancer Therapy Response
An observational study of Breast Cancer, run by Corewell Health East at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diffusion Weighted Imaging and Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Mar 2010to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer who are scheduled to receive standard of care neoadjuvant chemotherapy prior to surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kristen Grant, RN contact
United States4 sites, 3 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Courtney Wille, 319-678-2718
James Holmes, Ph.D., jim-holmes@uiowa.edu
- Completed
OHSU Knight Cancer Institute
Portland, Oregon, 97239
- Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Wei Huang, Ph.D., 248-551-6468, wei.huang@corewellhealth.org
Wei Huang, Ph.D.
- Recruiting
University of Washington
Seattle, Washington, 98109
Savannah Partridge, Ph.D., 206-606-1306, scp3@uw.edu
Savannah Partridge, Ph.D.
About this study
Official title: Functional Magnetic Resonance Imaging Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Breast Cancer
- Being tested
- Diffusion Weighted Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Weighted ImagingProcedure or surgery
Also called Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI
Undergo DW-MRI
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo DCE-MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (multi-parametric MRI) | Patients undergo an MRI exam that includes standard anatomic scans, DCE-MRI, and DW-MRI at baseline, after first treatment cycle, at mid-point of treatment course, and after completion of neoadjuvant chemotherapy. Receives: Procedure: Diffusion Weighted Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy
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.
Measured: Through study completion, up to 5 years
Secondary outcomes (3)
Compare functional MRI biomarkers with tumor size measurement for assessment of residual cancer burden
MRI parameters Kᵗʳᵃⁿˢ, vₑ, kₑₚ, τᵢ, ADC, and LD derived from the MRI data obtained after completion of neoadjuvant chemotherapy but before surgery will be correlated with residual cancer burden (RCB) ranks (RCB I, II, and III) determined by standard of care pathologist review of surgical specimens. Correlation coefficients will be compared to determine if a functional MRI biomarker is more accurate than LD in assessing RCB ranks. In addition, all functional MRI biomarkers will be combined using a multivariate logistic regression model and compared with LD in assessing RCB ranks.
Measured: Through study completion, up to 5 years
Compare functional MRI biomarkers with tumor size measurement for prognosis of recurrence-free survival
MRI parameters Kᵗʳᵃⁿˢ, vₑ, kₑₚ, τᵢ, ADC, and LD derived from the MRI data obtained after completion of neoadjuvant chemotherapy but before surgery will be correlated with recurrence-free survival (in the unit of month) to determine if a functional MRI biomarker provides more accurate prognosis of five-year recurrence-free survival than LD. In addition, all functional MRI biomarkers will be combined using a multivariate logistic regression model and compared with LD in prognosis of recurrence-free survival.
Measured: Up to 5 years after study completion
Validation of Shutter-Speed dynamic contrast-enhanced (DCE) MRI as a robust method for prediction and evaluation of breast cancer response to neoadjuvant chemotherapy
DCE-MRI data will be collected from participants using a Siemens scanner at OHSU, a Philips scanner at University of Washington, and a General Electric (GE) scanner at University of Iowa. The Shutter-Speed pharmacokinetic model will be used to analyze DCE-MRI data from each site to derive Kᵗʳᵃⁿˢ, vₑ, kₑₚ, and τᵢ parameters. As described above, ROC AUC value for prediction of response to neoadjuvant chemotherapy and correlation coefficient with RCB ranks will be calculated for each functional DCE-MRI biomarker. The ROC AUC value and correlation coefficient for each functional DCE-MRI biomarker will be compared across the three scanners (or three sites), respectively, to determine if the functional DCE-MRI biomarkers derived with the Shutter-Speed pharmacokinetic model provide similar predictive performances regardless of the MRI scanner vendor.
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start18 Mar 2010
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Washington, University of Iowa, Oregon Health and Science University
- Responsible party
- Principal investigator, Wei Huang, Corewell Health East
- Investigators
- Wei Huang, Ph.D., Principal investigator, Corewell Health William Beaumont University Hoospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704062
- Sponsor's protocol ID
- 2025-000
- Other IDs
- R01CA248192, NCI-2020-05192, IRB00005492
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05704062
- Acronym / sponsor ID
- 2025-000
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Washington, University of Iowa, Oregon Health and Science University
- Study start
- 18 Mar 2010 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (multi-parametric MRI) | – | Procedure: Diffusion Weighted Imaging, Procedure: Dynamic Contrast-Enhanced Magnetic Resonance ImagingPatients undergo an MRI exam that includes standard anatomic scans, DCE-MRI, and DW-MRI at baseline, after first treatment cycle, at mid-point of treatment course, and after completion of neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer who are scheduled to receive standard of care neoadjuvant chemotherapy prior to surgery.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion Weighted ImagingAlso: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRIUndergo DW-MRI | Procedure or surgery | Diagnostic (multi-parametric MRI) |
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo DCE-MRI | Procedure or surgery | Diagnostic (multi-parametric MRI) |
Primary outcome
Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy
Time frame: Through 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.
3 secondary outcomes
Compare functional MRI biomarkers with tumor size measurement for assessment of residual cancer burden
Time frame: Through study completion, up to 5 years
Compare functional MRI biomarkers with tumor size measurement for prognosis of recurrence-free survival
Time frame: Up to 5 years after study completion
Validation of Shutter-Speed dynamic contrast-enhanced (DCE) MRI as a robust method for prediction and evaluation of breast cancer response to neoadjuvant chemotherapy
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen Grant, RN contact
Wei Huang, Ph.D. principal investigator
Corewell Health William Beaumont University Hoospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Corewell Health East at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Huang, Chief, MR Rad Imaging Physics, PhD (248-551-6468, wei.huang@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy (time frame: Through study completion, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.