Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with breast lesions | Women with an identified breast lesion have a non-invasive non-contrast MRI scan prior to biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of BIT-Motion software | Diagnostic Test | Software program to discern benign versus malignant breast lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic diagnosis | MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis | One month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This three-year pilot study will be designed in two parts. The first phase will be a test phase, in which 10 volunteers (5 healthy volunteers and 5 volunteers with a known breast mass) will undergo a non-contrast breast MRI with non-fat-saturation T2 weighted imaging followed by a DTI protocol. The DTI data will be analyzed using the BIT-Motion software. During this phase, the scan technique and data analysis process will be optimized on the equipment at NorthShore University Healthsystem.
The second phase will then proceed with an accrual goal of 110 patients, scanning, data acquisition and analysis. The total accrual for this project is 120 subjects.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacob S Ecanow, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided