Enrolling by invitationNCT05486520Updated Oct 7, 2026

Low-field MRI for Breast Cancer Screening

An interventional study of Magnetic Resonance Imaging (MRI) in Breast Benign, Malignant Neoplasm of Breast and Breast Malignant Tumor, sponsored by Massachusetts General Hospital. Enrolling by invitation at 1 site in United States. Open to female participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic

Updated Oct 7, 2026Primary completion movedStudy completion movedGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 20 Years to 80 Years
Sex: Female

Study summary

This research study wants to learn more about improving the attainable image quality for ultra-low field MRI of the breast using new data acquisition methods(also called MRI pulse sequences) and image reconstruction algorithms.

For this pilot study, are testing a new method to image breast cancers at ultra-low magnetic field. The findings from this breast imaging technique will be compared with results obtained from standard mammograms, ultrasounds, MRIs, clinical examinations, and pathology evaluations, when available. The ultra-low field breast MRI performed for this study will be for research purposes and will not be used to guide clinical care.

Read the detailed description

This research study is a Feasibility Study, which is the first-time investigators are examining the use of ultra-low field MRI to image breast cancer.

The purpose of the study is to develop, test and improve new software techniques for our magnetic resonance imaging (MRI) systems. In developing new, ultra-low field MRI scanners develop sequences and other software algorithms from time to time.

This study will enroll both healthy participants and persons with breast cancer. This investigation will also compare these images to standard mammograms, ultrasounds, MRIs, clinical examinations, and pathology evaluations when available.

It is expected that about 40 people will take part in this research study.

Conditions studied

Breast Benign
Malignant Neoplasm of Breast
Breast Malignant Tumor

Browse trials for

Breast Neoplasms 12,544

Keywords

Breast pathologies benign
Breast pathologies malignant

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 80 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria:

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.
Subjects will undergo MR contraindication screening to ensure that they meet the basic inclusion/exclusion criteria for the study and give written informed consent immediately prior to the MR imaging study.
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 Criteria:

Exclusion criteria include MR contraindications
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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Active comparator
BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS
All participants will be recruited prior to their scheduled diagnostic imaging or diagnostic procedures. The expected time to complete the study is a maximum of 1.5 hours with approximately 30-60 minutes of scan time, depending on the specific MRI software being tested.
Device: Magnetic Resonance Imaging (MRI)
Experimental
BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT
All participants will be recruited prior to their scheduled diagnostic imaging or diagnostic procedures. The expected time to complete the study is a maximum of 1.5 hours with approximately 30-60 minutes of scan time, depending on the specific MRI software being tested.
Device: Magnetic Resonance Imaging (MRI)

Interventions

DeviceMagnetic Resonance Imaging (MRI)
MR images will be acquired using an ultra-low magnetic field 6.5 mT scanner located at the Martinos Center. The study time is estimated to be a maximum of 90 minutes with a maximum of 60 minutes of imaging time

What researchers measure

Primary outcomes

T1rho dispersion signal
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).
Time frame: 1 year

Study locations

1 site

Massachusetts General Hospital
Boston, Massachusetts 02115, United States

References and documents

Individual participant data

Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Primary completion

Sep 15, 2026→Sep 15, 2028

Oct 7, 2026

Study completion

Oct 1, 2026→Oct 1, 2028

Oct 7, 2026

Show all 1 update

Oct 7, 2026
Primary completion Sep 15, 2026→Sep 15, 2028
Study completion Oct 1, 2026→Oct 1, 2028
+ 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05486520
Lead sponsor: Massachusetts General Hospital
Collaborators: National Institutes of Health (NIH)
Responsible party: Matthew S. Rosen, Ph.D. (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted: Aug 3, 2022
Start date: Sep 1, 2022
Primary completion: Sep 15, 2028 (estimated)
Completion: Oct 1, 2028 (estimated)
Last update: Oct 7, 2026

Study contacts

Matthew S Rosen, Ph.D

principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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