Advanced Diffusion Tensor MRI for Breast Cancer

Endeavor Health

Status: Completed

Conditions: Breast Cancer; Breast Diseases

Treatments: Diagnostic Test: Evaluation of BIT-Motion software

Study type: Observational

Funder types: Other

Identifiers

NCT04774471

EH20-251

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

68 participants in 1 patient group

Women with breast lesions

Description:

Women with an identified breast lesion have a non-invasive non-contrast MRI scan prior to biopsy.

Treatment:

Diagnostic Test: Evaluation of BIT-Motion software