Advanced Diffusion Tensor MRI for Breast Cancer

Endeavor Health68 enrolled

Overview

The purpose of this research is to evaluate the accuracy of the BIT-Motion (Breast Imaging Tensor-Motion) software with non-contrast MRI scanning to detect breast cancer.

The goal of this study is to answer the question: what is the ability of the BIT-Motion (Breast Imaging Tensor-Motion) software to detect and discriminate between benign and malignant breast lesions that are identified on mammogram (MG) and ultrasound (US) examinations. Women over the age of 18 who have a breast lesion that is seen on MG or US will be eligible to enroll. Participation in this study will involve one non-invasive non-contrast MRI scan of the breasts.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Breast Diseases

Interventions

Evaluation of BIT-Motion softwareDIAGNOSTIC_TEST

Software program to discern benign versus malignant breast lesions.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female * scheduled for ultrasound or stereotactic guided breast biopsy * \> 18 years of age * able to tolerate up to 90 minutes in the MRI scanner Exclusion Criteria: * Male * Has a medical condition that, in the opinion of the investigator, puts the subject at significant risk * Has any contraindication to the MRI examination as determined by standard NorthShore University Health System relative to MRI safety * Cannot comprehend or complete the Informed Consent Form

Locations (1)

NorthShore University Health System

Evanston, Illinois, United States

Outcomes

Primary Outcomes

Pathologic diagnosis

MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis

Time frame: One month

Data from ClinicalTrials.gov

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