Back to resultsMIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast MRI
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring Breast Cancer, Screening, Artificial Intelligence
Eligibility Criteria
Inclusion Criteria: Women who were identified as high risk on the retrospective study (dating from 2017-2023) using MIRAI will be recruited and consented for the prospective study Women over 40 years of age identified as high risk according to traditional guidelines will also be potentially eligible for this study Following consent and enrollment in the study, a participant will subsequently receive the following: These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection. Any positive diagnosis on MRI will be followed by biopsy to confirm 'truth" of diagnosis. To be selected, a given record must include the following: A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system. Reports of all follow up screening and diagnostic studies documented on PACS. Some may have interventional procedures (as long as all of these are done at one of Umass sites) and documentation of these biopsy results in the hospitals EHR. Exclusion Criteria: Under age 40. Women under 40 years are not routinely xrayed with a mammogram. Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation. Pregnant patients because they do not routinely receive screening mammogram Adult male patients with breast cancer
Sites / Locations
- UMass Medical School
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Breast MRI Screening for High Risk Patients
Arm Description
Breast MRI will be recommended for patients who are deemed high risk by either the traditional model (Tyrer Cusick) or the Mirai model.
Outcomes
Primary Outcome Measures
CDR Mirai Assessment versus CDR Traditional High Risk Screening
Cancer detection rate from breast MRI following Mirai assessment of high risk on a screening mammogram performed less than 1 year ago and compared with established CDR in traditional high risk screening.
Secondary Outcome Measures
Cancer development within study population versus general population of average risk women
On subsequent follow-up with standard of care, assessment of what percentage of the study population develops breast cancer as compared to the general population of women at average risk of breast cancer.
Full Information
NCT ID
NCT05968157
First Posted
July 21, 2023
Last Updated
August 4, 2023
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT05968157
Brief Title
MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
Official Title
MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Accurate risk assessment is essential for the success of population screening programs and early detection efforts in breast cancer. Mirai is a new deep learning model based on full resolution mammograms.
Mirai is a mammography-based deep learning model designed to predict risk at multiple timepoints, leverage potentially missing risk factor information, and produce predictions that are consistent across mammography machines. Mirai was trained on a large dataset from Massachusetts General Hospital (MGH) in the United States and found to be significantly more accurate than the Tyrer-Cuzick model, a current clinical standard.
The primary aim of this study is to prospectively quantify the clinical benefit (i.e. MRI/CEM cancer detection rate) of Mirai-based guidelines and to compare them to the current standard of care.
Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months.
Compare cancer outcomes between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines The secondary aim is to study the impact of new guidelines by race and ethnicity, to ensure equitable improvements in cancer screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Screening, Artificial Intelligence
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breast MRI Screening for High Risk Patients
Arm Type
Other
Arm Description
Breast MRI will be recommended for patients who are deemed high risk by either the traditional model (Tyrer Cusick) or the Mirai model.
Intervention Type
Procedure
Intervention Name(s)
Breast MRI
Intervention Description
Patients who are identified as high risk for breast cancer by Mirai guidelines are invited to receive supplemental MRI. In addition, the patients eligible for MRI screening according to other guidelines will also be screened to collect additional comparison data. Cancer outcomes will then be compared between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines.
Primary Outcome Measure Information:
Title
CDR Mirai Assessment versus CDR Traditional High Risk Screening
Description
Cancer detection rate from breast MRI following Mirai assessment of high risk on a screening mammogram performed less than 1 year ago and compared with established CDR in traditional high risk screening.
Time Frame
1.5 years (duration of patient recruitment and outcome data collection)
Secondary Outcome Measure Information:
Title
Cancer development within study population versus general population of average risk women
Description
On subsequent follow-up with standard of care, assessment of what percentage of the study population develops breast cancer as compared to the general population of women at average risk of breast cancer.
Time Frame
1.5 years (duration of patient recruitment and outcome data collection)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who were identified as high risk on the retrospective study (dating from 2017-2023) using MIRAI will be recruited and consented for the prospective study
Women over 40 years of age identified as high risk according to traditional guidelines will also be potentially eligible for this study
Following consent and enrollment in the study, a participant will subsequently receive the following:
These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection.
Any positive diagnosis on MRI will be followed by biopsy to confirm 'truth" of diagnosis.
To be selected, a given record must include the following:
A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system.
Reports of all follow up screening and diagnostic studies documented on PACS.
Some may have interventional procedures (as long as all of these are done at one of Umass sites) and documentation of these biopsy results in the hospitals EHR.
Exclusion Criteria:
Under age 40. Women under 40 years are not routinely xrayed with a mammogram.
Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation.
Pregnant patients because they do not routinely receive screening mammogram
Adult male patients with breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Schiller, MPH
Phone
7744417731
Email
sara.schiller1@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Shazeeb, PhD
Organizational Affiliation
UMass Chan Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Shazeeb, PhD
Phone
508-856-4255
Email
mohammed.shazeeb@umassmed.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
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