Advanced Diffusion Tensor MRI for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-03

Study Completion Date

2023-05-18

Brief Summary

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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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Detailed Description

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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

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Breast Cancer Breast Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with breast lesions

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

Evaluation of BIT-Motion software

Intervention Type DIAGNOSTIC_TEST

Software program to discern benign versus malignant breast lesions.

Interventions

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Evaluation of BIT-Motion software

Software program to discern benign versus malignant breast lesions.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes