Advanced Diffusion Tensor MRI for Breast Cancer

• Sponsor: NorthShore University HealthSystem (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04774471
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Breast Diseases	Diagnostic Test: Evaluation of BIT-Motion software

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 Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Advanced Diffusion Tensor MRI for Breast Cancer
• Actual Study Start Date: Feb 3, 2021
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Pathologic diagnosis [One month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University Health System	Evanston	Illinois	United States	60201

Sponsors and Collaborators

• NorthShore University HealthSystem

Investigators

• Principal Investigator: Jacob S Ecanow, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacob Ecanow, M.D., FPA, NorthShore University HealthSystem
• ClinicalTrials.gov Identifier: NCT04774471
• Other Study ID Numbers: EH20-251
• First Posted: Mar 1, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• 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
• Keywords provided by Jacob Ecanow, M.D., FPA, NorthShore University HealthSystem: Diffusion Tensor Imaging; MRI
• Additional relevant MeSH terms: Breast Neoplasms; Breast Diseases

Study Results

No Results Posted as of Apr 6, 2022