Clinical trial NCT02058758: Quantitative Methods for Supplementing Contrast-Enhanced Magnetic Resonance Imaging of Breast Cancer
Official title: Quantitative Methods for Supplementing Contrast-Enhanced Magnetic Resonance Imaging of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
Magnetic resonance spectroscopy
Diffusion weighted imaging
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of choline-containing metabolites
timeFrame: Baseline
Secondary outcomes:
measure: The apparent diffusion coefficient and T2 relaxation rate of water in the tumor
timeFrame: Baseline and 6 months following treatment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Center for Clinical Imaging Reserach
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Patrick Bolan, PhD
role: PRINCIPAL_INVESTIGATOR
References: