CClinicalTrials.gg
CompletedNCT02058758Updated Sep 25, 2019

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

An observational study in Breast Cancer, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Breast cancer
  • Magnetic resonance spectroscopy
  • Diffusion weighted imaging
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 80 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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)

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Volunteers

    Device: Magnetic Resonance Imaging

    Device: Magnetic Resonance Imaging

  • Breast Cancer Patients

    Device: Magnetic Resonance Imaging

    Device: Magnetic Resonance Imaging

Interventions

  • DeviceMagnetic Resonance Imaging

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline and 6 months following treatment

07

Study locations

1 site
  • University of Minnesota Center for Clinical Imaging Reserach
    Minneapolis, Minnesota 55455, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02058758
Lead sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 10, 2014
Start date
Mar 1, 2014
Primary completion
Jul 1, 2019
Completion
Sep 1, 2019
Last update
Sep 25, 2019

Study contacts

Patrick Bolan, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion