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Completed

NCT Number: NCT04774471

Advanced Diffusion Tensor MRI for Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

NorthShore University Health System

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of BIT-Motion software

Diagnostic Test

Software program to discern benign versus malignant breast lesions.

Primary outcomes

  1. Pathologic diagnosis

    Time frame: One month

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

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2021
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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