NCT05486520

Low-field MRI for Breast Cancer Screening

Enrolling by Invitation
NAAges 20–80InterventionalDiagnostic
Massachusetts General Hospital
~40 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Magnetic Resonance Imaging (MRI)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
T1rho dispersion signal
Measured over 1 year
Breast Benign
Malignant Neoplasm of Breast
Breast Malignant Tumor
1 sites across 1 states
Massachusetts1
  • Matthew S Rosen, Ph.D · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Informed consent will be obtained from the adult volunteer subjects by the principal investigator, the coinvestigators, or the study staff prior to the imaging session. The investigator obtaining consent will explain in detail the protocol of the study, its purpose, and potential benefits to the society.
Subjects will be informed about the minimal risks of ultra-low magnetic fields) and of low-frequency nonionizing RF radiation involved in ultra-low field MR imaging. Subjects will also be informed about small space within the magnet. Unlike high-field scanners, there is essentially no sound produced by the imaging gradients, so hearing protection is not required.
Subjects will be informed that if they feel uncomfortable with the study, they can choose to terminate the study at any time. They will be informed that their refusal to participate in the study or choosing to terminate it at some point will have no effect on care and treatment received by them at MGH now or in future.
The subjects will be informed that their personal information will be protected as per the HIPAA guidelines.
The subjects will have at least 15 minutes to consider participation.
Recruit adult female volunteers of any race or ethnic background, between the ages of 20 to 80, who are either scheduled for breast imaging and/or a percutaneous biopsy.
All efforts will be taken to find interpreters for volunteers who do not understand English, enabling them to be screened and consented with the short-form consent form so that they may participate in this study.

Exclusion

Electronic implants such as cardiac pacemakers or perfusion pumps
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
Ferromagnetic objects such as jewelry or metal clips in clothing
Pregnant or breast feeding women
A history of uncontrolled seizures
Claustrophobia
Any greater than normal potential for cardiac arrest
Subjects less than 18 years of age or over 80 years of age.
  • T1rho dispersion signal1 year

    Student's t-test to compare T1rho dispersion: a) in all participants between fat and fibroglandular tissues (expected difference); b) in patients between fat and cancer tissues (expected difference); and c) in patients between fibroglandular and cancer tissues (expected difference in dispersion curve).