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Advanced Diffusion Tensor MRI for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774471
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jacob Ecanow, NorthShore University HealthSystem

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pathologic diagnosis [ Time Frame: One month ]
    MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.

Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774471


Contacts
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Contact: Jacob Ecanow, MD (847) 570-1839 JEcanow@northshore.org
Contact: Claire Feczko (847) 570-1839 CFeczko@northshore.org

Locations
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United States, Illinois
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Study Coordinator         
Contact: Principle Investigator         
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Jacob S Ecanow, MD NorthShore University HealthSystem
More Information
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Responsible Party: Jacob Ecanow, M.D., FPA, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT04774471    
Other Study ID Numbers: EH20-251
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jacob Ecanow, NorthShore University HealthSystem:
Diffusion Tensor Imaging
MRI
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases