- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704062
Quantitative MRI Assessment of Breast Cancer Therapy Response
Multi-Functional Magnetic Resonance Imaging Modalities for Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
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Contact:
- Courtney Wille
- Phone Number: 319-678-2718
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Principal Investigator:
- James Holmes, Ph.D.
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Contact:
- James Holmes, Ph.D.
- Email: jim-holmes@uiowa.edu
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- OHSU Knight Cancer Institute
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Contact:
- Wei Huang, Ph.D.
- Phone Number: 503-418-1534
- Email: huangwe@ohsu.edu
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Principal Investigator:
- Wei Huang, Ph.D.
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Washington
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Seattle, Washington, United States, 98109
- Recruiting
- University of Washington
-
Contact:
- Savannah Partridge, Ph.D.
- Phone Number: 206-606-1306
- Email: scp3@uw.edu
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Principal Investigator:
- Savannah Partridge, Ph.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Undergo DCE-MRI
Other Names:
Undergo DW-MRI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare functional MRI biomarkers with tumor size measurement for assessment of residual cancer burden
Time Frame: Through study completion, up to 5 years
|
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.
|
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
|
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.
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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
|
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.
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Through study completion, up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wei Huang, Ph.D., OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00005492 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2020-05192 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA248192 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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