Trial Title:
Quantitative MRI Assessment of Breast Cancer Therapy Response
NCT ID:
NCT05704062
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Diffusion Weighted Imaging
Description:
Undergo DW-MRI
Arm group label:
Diagnostic (multi-parametric MRI)
Other name:
Diffusion Weighted MRI
Other name:
Diffusion-Weighted Magnetic Resonance Imaging
Other name:
Diffusion-Weighted MR Imaging
Other name:
Diffusion-Weighted MRI
Other name:
DW-MRI
Other name:
DWI
Other name:
DWI MRI
Other name:
DWI-MRI
Other name:
MR Diffusion-Weighted Imaging
Intervention type:
Procedure
Intervention name:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Description:
Undergo DCE-MRI
Arm group label:
Diagnostic (multi-parametric MRI)
Other name:
DCE
Other name:
DCE MRI
Other name:
DCE-MRI
Other name:
DYNAMIC CONTRAST ENHANCED MRI
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.
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.
Criteria for eligibility:
Study pop:
Patients with breast cancer who are scheduled to receive standard of care neoadjuvant
chemotherapy prior to surgery.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Courtney Wille
Phone:
319-678-2718
Contact backup:
Last name:
James Holmes, Ph.D.
Email:
jim-holmes@uiowa.edu
Investigator:
Last name:
James Holmes, Ph.D.
Email:
Principal Investigator
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wei Huang, Ph.D.
Phone:
503-418-1534
Email:
huangwe@ohsu.edu
Investigator:
Last name:
Wei Huang, Ph.D.
Email:
Principal Investigator
Facility:
Name:
University of Washington
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Savannah Partridge, Ph.D.
Phone:
206-606-1306
Email:
scp3@uw.edu
Investigator:
Last name:
Savannah Partridge, Ph.D.
Email:
Principal Investigator
Start date:
March 18, 2010
Completion date:
November 30, 2026
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
University of Iowa
Agency class:
Other
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704062
