RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Magnetic resonance imaging (MRI) for Cancer Risk

This is a multi-center, single arm trial to measure the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.

Official registry: https://clinicaltrials.gov/study/NCT07121972 · University of California, San Francisco · enrollment listed as 400

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Magnetic resonance imaging (MRI), or Artificial Intelligence (AI). The registry lists allocation as na. This is a multi-center, single arm trial to measure the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment.

They plan to enroll about 400 people at 4 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk

Interventions: Magnetic resonance imaging (MRI), Artificial Intelligence (AI)

Primary outcome (registry wording): Cancer detection rate (CDR)

Who it is for (from inclusion criteria)

Ages 40 Years to 89 Years
Women only
All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or initial BI-RADS 0 with subsequent diagnostic mammogram assessed as BI-RADS 1 or BI-RADS 2
Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk)
Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the corresponding Digital Imaging and Communications in Medicine (DICOM) images

Who the registry excludes

Screening mammogram that is assessed as BI-RADS 0 for technical recall
Contraindications for MRI:
Metallic foreign body in the eye
MRI unsafe implants and/or medical devices
Adverse reaction to a (gadolinium-based) contrast agent in the past
Exceeds site specific size and/or weight limit for MRI
History of "kidney disease" as an adult, including renal tumor or transplant

Public study contact (from the registry)

Tiffany Tran

877-827-3222

tiffany.tran3@ucsf.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

University of California, San Diego — San Diego, California (not_yet_recruiting)
University of California, San Francisco — San Francisco, California (recruiting)
University of Chicago Comprehensive Cancer Center — Chicago, Illinois (not_yet_recruiting)
University of Massachusetts Memorial Medical Center — Worcester, Massachusetts (recruiting)

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FAQ about this NCT record

Is NCT07121972 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07121972?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07121972?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary