Quantitative Methods for Supplementing Contrast-Enhanced Magnetic Resonance Imaging of Breast Cancer

Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high sensitivity because the intravenous MR contrast agent highlights regions with increased vascularization and vascular permeability compared to normal breast tissues and benign lesions.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Magnetic Resonance Imaging

Detailed Description

Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high sensitivity because the intravenous MR contrast agent highlights regions with increased vascularization and vascular permeability compared to normal breast tissues and benign lesions. While research continues on improving the specificity of CE-MRI, several other MR techniques that do not require an exogenous contrast agent have been shown to provide valuable information that can improve the characterization of breast cancers. These techniques include magnetic resonance spectroscopy (MRS), diffusion-weighted imaging, and water T2 relaxometry. The long-term goal of this study is to develop these techniques to produce quantitative MR-based biomarkers that can be used to supplement or possibly supplant the information provided by CE-MRI. This project seeks to facilitate the advancement of these advanced, non-contrast techniques. This study uses a piggyback design, in which subjects who are already scheduled to receive a CE-MRI study are invited to receive an additional 10-20 minutes of scanning to help develop these novel methods. This efficient design allows for the refinement and assessment of these new techniques with a minimum of risk and inconvenience to the patient. With these proposed improvements, these techniques may lead to quantitative biomarkers that can guide critical clinical questions in treatment response, diagnosis, staging, and high-risk screening of breast cancer.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Center for Clinical Imaging Reserach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients: recruited from the group of patients that have a known cancer and are scheduled to receive a breast MRI at the UMN Center for Clinical Imaging Research (CCIR)

Description

Inclusion Criteria:

• Women scheduled and eligible to receive a contrast-enhanced breast MRI at the UMN Center for Clinical Imaging Research for either standard clinical care, or participation in the ISPY2/ACRIN6698 clinical research study
• Age 18 years or older
• Ability to read and understand English
• Ability to provide written informed consent

Exclusion Criteria:

• Subjects who are unlikely to tolerate the longer MRI scanning duration. This may include, history of discomfort during MRI scanning, anxiety, or claustrophobia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Device: Magnetic Resonance Imaging	Device: Magnetic Resonance Imaging; MRI scanning with novel acquisition, reconstruction, and/or analysis methods.
Breast Cancer Patients; Device: Magnetic Resonance Imaging	Device: Magnetic Resonance Imaging; MRI scanning with novel acquisition, reconstruction, and/or analysis methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of choline-containing metabolites	Demonstration of the feasibility of using SLIM-based techniques for acquiring spectoscopic data for quantifying choline and other metabolites in breast cancer.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The apparent diffusion coefficient and T2 relaxation rate of water in the tumor	Develop and optimize methods for performing diffusion weighted imaging and T2 relaxometry in breast cancer.	Baseline and 6 months following treatment

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Patrick Bolan, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; Magnetic resonance spectroscopy; Diffusion weighted imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1312M4621; R21CA179070 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED