Advanced Diffusion Tensor MRI for Breast Cancer

Active, not recruiting

• Conditions: Breast Diseases; Breast Cancer
• Interventions: Diagnostic Test: Evaluation of BIT-Motion software

• Registration Number: NCT04774471
• Lead Sponsor: NorthShore University HealthSystem

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.

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 Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 68

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with breast lesions	Evaluation of BIT-Motion software	Women with an identified breast lesion have a non-invasive non-contrast MRI scan prior to biopsy.

Primary Outcome Measures

Name	Time	Method
Pathologic diagnosis	One month	MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis

Trial Locations

Locations (1)

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States