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

Completed

• Conditions: Breast Cancer
• Interventions: Device: Magnetic Resonance Imaging

• Registration Number: NCT02058758
• Lead Sponsor: University of Minnesota

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Study Start: 2014-03-01
• Primary Completion: 2019-07-01
• Status Verified: 2019-09
• Study Completion: 2019-09-01
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Magnetic Resonance Imaging	Device: Magnetic Resonance Imaging
Breast Cancer Patients	Magnetic Resonance Imaging	Device: Magnetic Resonance Imaging

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota Center for Clinical Imaging Reserach; 🇺🇸 Minneapolis, Minnesota, United States