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OpenTrials
Completed

NCT Number: NCT02058758

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota Center for Clinical Imaging Reserach

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Device

MRI scanning with novel acquisition, reconstruction, and/or analysis methods.

Primary outcomes

  1. Concentration of choline-containing metabolites

    Time frame: Baseline

    Demonstration of the feasibility of using SLIM-based techniques for acquiring spectoscopic data for quantifying choline and other metabolites in breast cancer.

Secondary outcomes

  1. The apparent diffusion coefficient and T2 relaxation rate of water in the tumor

    Time frame: Baseline and 6 months following treatment

    Develop and optimize methods for performing diffusion weighted imaging and T2 relaxometry in breast cancer.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 10, 2014
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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