Advanced Diffusion Tensor MRI for Breast Cancer

May 28, 2025 updated by: Jacob Ecanow, Endeavor Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Software program to discern benign versus malignant breast lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic diagnosis
Time Frame: One month
MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Investigators

  • Principal Investigator: Jacob S Ecanow, MD, Endeavor Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2021

Primary Completion (Actual)

May 18, 2023

Study Completion (Actual)

May 18, 2023

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH20-251

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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