Breast Cancer, Breast Diseases
Conditions
Keywords
Diffusion Tensor Imaging, MRI
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.
Interventions
DIAGNOSTIC_TESTEvaluation of BIT-Motion software
Software program to discern benign versus malignant breast lesions.
Sponsors
Endeavor Health
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic diagnosis | One month | MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis |
Countries
United States
Outcome results
None listed