Trials / Completed
CompletedNCT04774471
Advanced Diffusion Tensor MRI for Breast Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 68 (actual)
- Sponsor
- Endeavor Health · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Evaluation of BIT-Motion software | Software program to discern benign versus malignant breast lesions. |
Timeline
- Start date
- 2021-02-03
- Primary completion
- 2023-05-18
- Completion
- 2023-05-18
- First posted
- 2021-03-01
- Last updated
- 2025-06-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04774471. Inclusion in this directory is not an endorsement.