Advanced Diffusion Tensor MRI for Breast Cancer
- Conditions
- Breast DiseasesBreast Cancer
- Registration Number
- NCT04774471
- Lead Sponsor
- Endeavor Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 68
- Female
- scheduled for ultrasound or stereotactic guided breast biopsy
- > 18 years of age
- able to tolerate up to 90 minutes in the MRI scanner
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathologic diagnosis One month MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
NorthShore University Health System🇺🇸Evanston, Illinois, United States