Clinical trial NCT05704062: Quantitative MRI Assessment of Breast Cancer Therapy Response
Official title: Functional Magnetic Resonance Imaging Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Washington
name: University of Iowa
name: Oregon Health and Science University
First posted: 2023-01-30
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer who are scheduled to receive standard of care neoadjuvant chemotherapy prior to surgery.

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.

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.

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

Primary outcomes:
measure: Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy
timeFrame: Through study completion, up to 5 years
Secondary outcomes:
measure: Compare functional MRI biomarkers with tumor size measurement for assessment of residual cancer burden
timeFrame: Through study completion, up to 5 years
measure: Compare functional MRI biomarkers with tumor size measurement for prognosis of recurrence-free survival
timeFrame: Up to 5 years after study completion
measure: Validation of Shutter-Speed dynamic contrast-enhanced (DCE) MRI as a robust method for prediction and evaluation of breast cancer response to neoadjuvant chemotherapy
timeFrame: Through study completion, up to 5 years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Corewell Health William Beaumont University Hoospital
name: Wei Huang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: