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Procedure
MRI Screening for High-Risk Breast Cancer Detection
N/A
Recruiting
Led By Mohammed Shazeeb, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years (duration of patient recruitment and outcome data collection)
Awards & highlights
Study Summary
This trial is testing a deep learning model, Mirai, to accurately predict breast cancer risk. It will compare cancer outcomes between patients identified as high-risk by Mirai vs. existing guidelines and study its impact by race/ethnicity.
Who is the study for?
This trial is for women over 40 identified as high risk for breast cancer using the Mirai model or traditional guidelines. They must have had a mammogram at Umass sites with results in the EHR and be willing to undergo an MRI. Pregnant women, those under 40, men, and anyone with poor quality mammogram images are excluded.Check my eligibility
What is being tested?
The MIRAI-MRI study is testing if screening MRIs based on high-risk assessments from a new AI model called Mirai can better detect breast cancer compared to current standards. It involves comparing outcomes of patients identified by Mirai against those by traditional methods.See study design
What are the potential side effects?
While not directly related to side effects, undergoing an MRI may involve discomfort due to the enclosed space and loud noises during the procedure. There's also a small risk of allergic reaction to contrast agents used in some MRIs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years (duration of patient recruitment and outcome data collection)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years (duration of patient recruitment and outcome data collection)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CDR Mirai Assessment versus CDR Traditional High Risk Screening
Secondary outcome measures
Cancer development within study population versus general population of average risk women
Trial Design
1Treatment groups
Experimental Treatment
Group I: Breast MRI Screening for High Risk PatientsExperimental Treatment1 Intervention
Breast MRI will be recommended for patients who are deemed high risk by either the traditional model (Tyrer Cusick) or the Mirai model.
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Who is running the clinical trial?
University of Massachusetts, WorcesterLead Sponsor
343 Previous Clinical Trials
986,110 Total Patients Enrolled
5 Trials studying Breast Cancer
38,384 Patients Enrolled for Breast Cancer
Mohammed Shazeeb, PhDPrincipal InvestigatorUMass Chan Medical School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If my MRI shows something unusual, I will need a biopsy to confirm the diagnosis.I am a woman over 40 and considered high risk for breast cancer.I have had procedures done at a Umass site and the results are in the hospital's records.I am a man diagnosed with breast cancer.I am eligible for a highly sensitive breast cancer detection MRI.You have had a recent mammogram and can provide the images from the test.Your breast cancer screening X-ray has unclear or distorted images.I am under 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Breast MRI Screening for High Risk Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this clinical experiment that potential participants can take advantage of?
"According to clinicaltrials.gov, the initial posting of this trial was on August 1st 2023 and it has not been recruiting patients since being edited on July 21st 2023. Nevertheless, there are 2,654 other medical studies taking in participants at present."
Answered by AI
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