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

NCT02058758 | Completed DMC

• 2 other identifiers: 1312M4621R21CA179070
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Magnetic resonance spectroscopy; Diffusion weighted imaging

Outcome Measures

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.

  Baseline

Secondary Outcomes (1)

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

  Baseline and 6 months following treatment

Study Arms (2)

Healthy Volunteers

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Imaging

Breast Cancer Patients

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DEVICE

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

Breast Cancer Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Minnesota Center for Clinical Imaging Reserach

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Patrick Bolan, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 10, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)