Quantitative MRI Assessment of Breast Cancer Therapy Response

OHSU Knight Cancer Institute

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Diffusion Weighted Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05704062

NCI-2020-05192 (Registry Identifier)

IRB00005492 (Other Identifier)

R01CA248192 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

135 participants in 1 patient group

Diagnostic (multi-parametric MRI)

Description:

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.

Treatment:

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Procedure: Diffusion Weighted Imaging