Breast CancerNCT04774471
Advanced Diffusion Tensor MRI for Breast Cancer
An observational study of Breast Cancer and Breast Diseases, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Diseases
- What is being tested?
- Evaluation of BIT-Motion software
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 18 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Female
- scheduled for ultrasound or stereotactic guided breast biopsy
- > 18 years of age
- able to tolerate up to 90 minutes in the MRI scanner
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University Health System
Evanston, Illinois, 60201
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Diseases
- Being tested
- Evaluation of BIT-Motion software
- Keywords
- Diffusion Tensor Imaging, MRI
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of BIT-Motion softwareDiagnostic test
Software program to discern benign versus malignant breast lesions.
| Study group | Role | What they receive |
|---|---|---|
| Women with breast lesions | Women with an identified breast lesion have a non-invasive non-contrast MRI scan prior to biopsy. Receives: Diagnostic Test: Evaluation of BIT-Motion software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic diagnosis
MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start3 Feb 2021
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Ecanow, Endeavor Health
- Investigators
- Jacob S Ecanow, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774471
- Sponsor's protocol ID
- EH20-251
- Status last verified
- May 2025
- First submitted
- 24 Feb 2021
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Diffusion Tensor MRI for Breast Cancer
- ClinicalTrials.gov ID
- NCT04774471
- Acronym / sponsor ID
- EH20-251
- Conditions
- Breast Cancer, Breast Diseases
- Keywords
- Diffusion Tensor Imaging, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with breast lesions | – | Diagnostic Test: Evaluation of BIT-Motion softwareWomen with an identified breast lesion have a non-invasive non-contrast MRI scan prior to biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Female
- scheduled for ultrasound or stereotactic guided breast biopsy
- > 18 years of age
- able to tolerate up to 90 minutes in the MRI scanner
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of BIT-Motion softwareSoftware program to discern benign versus malignant breast lesions. | Diagnostic test | Women with breast lesions |
Primary outcome
Pathologic diagnosis
Time frame: One month
MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob S Ecanow, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Diseases, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic diagnosis (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.