Advanced Diffusion Tensor MRI for Breast Cancer

NCT04774471 | Completed FDA Device

• 1 other identifier: EH20-251
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Diseases

Keywords

Diffusion Tensor Imaging; MRI

Outcome Measures

Primary Outcomes (1)

• Pathologic diagnosis

  MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis

  One month

Study Arms (1)

Women with breast lesions

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

Diagnostic Test: Evaluation of BIT-Motion software

Interventions

Evaluation of BIT-Motion software DIAGNOSTIC_TEST

Software program to discern benign versus malignant breast lesions.

Women with breast lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Female
• scheduled for ultrasound or stereotactic guided breast biopsy
• \> 18 years of age
• able to tolerate up to 90 minutes in the MRI scanner

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacob S Ecanow, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., FPA

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: February 3, 2021
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

US (1)