Low-field MRI for Breast Cancer Screening

MS
Overseen ByMatthew S. Rosen, Ph.D
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for imaging the breast using an ultra-low magnetic field MRI, a type of imaging technology. The goal is to determine if these images can match or surpass the results from standard imaging methods like mammograms and ultrasounds. The trial is solely for research purposes and will not affect any medical treatment decisions. It is suitable for adult women scheduled for breast imaging or a biopsy, who do not have metal implants or severe claustrophobia. As an unphased trial, this study offers a unique opportunity to contribute to advancements in breast imaging technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study staff or your doctor.

What prior data suggests that this imaging method is safe for breast cancer screening?

Research has shown that low-field MRI is safe for breast imaging. Studies indicate it can identify important breast features without harmful radiation or injected dyes. Early research suggests this type of MRI is comfortable for patients and avoids radiation exposure, reassuring those concerned about safety. Although more research is needed, initial findings demonstrate its practicality and comfort for patients. Overall, low-field MRI appears to be a safe choice for breast imaging.12345

Why are researchers excited about this trial?

Researchers are excited about using low-field MRI for breast cancer screening because it offers a safer and potentially more accessible imaging option compared to traditional high-field MRI and mammography. Unlike high-field MRI, low-field MRI uses a lower magnetic field strength, which may reduce costs and make the technology more widely available, especially in underserved areas. Additionally, it minimizes the risk of exposure to ionizing radiation, which is a concern with mammography. By evaluating both healthy volunteers and those with known breast pathologies, researchers hope to determine if low-field MRI can effectively identify breast cancer while being more accessible and safer for patients.

What evidence suggests that this imaging method is effective for breast cancer screening?

Studies have shown that low-field MRI can effectively detect important breast features and some abnormalities without using radiation or injected contrast. This trial will have participants undergo low-field MRI to assess its effectiveness. In healthy participants, ultra-low field (ULF) MRI provided clear images of breast tissue, which could help identify potential issues. Research indicates that MRI is often preferred for high-risk breast cancer screening because it can overcome certain limitations of mammography. This early evidence suggests that ULF MRI might offer a comfortable and widely accessible option for breast imaging. Although more research is needed, these promising results point to its potential as an effective screening tool.12467

Who Is on the Research Team?

MS

Matthew S Rosen, Ph.D

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adult women aged 20-80, scheduled for breast imaging or biopsy, who can give informed consent and have no issues with small spaces. It's not for those with certain metal implants, electronic devices like pacemakers, a history of uncontrolled seizures, claustrophobia, pregnancy/breastfeeding or under 18/over 80.

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.
I need an interpreter to participate in this study.
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Exclusion Criteria

I have a history of seizures that are not controlled.
You have metal implants or fragments in your body, or tattoos near your eye.
Ferromagnetic objects such as jewelry or metal clips in clothing
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo ultra-low field MRI scans for research purposes

1.5 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Low-field MRI

Trial Overview

The study is testing a new ultra-low field MRI technique to improve image quality in breast cancer screening. This method will be compared against standard mammograms and MRIs but won't influence current clinical care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANTExperimental Treatment1 Intervention
Group II: BREAST MRI IMAGES FROM HEALTHY VOLUNTEERSActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Breast imaging with ultra-low field MRI | Scientific Reports

In healthy participants, the ULF MR images of the whole breast revealed essential breast features, including type of fibroglandular tissue (FGT) ...

NCT05486520 | Low-field MRI for Breast Cancer Screening

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 ...

Screening Breast MRI Effectively Detects Early-Stage ... - PMC

Key Results: Breast MRI showed 93.3% sensitivity and 83.4% specificity for detecting breast cancer in an asymptomatic, high-risk screening ...

Study Shows Low-Field MRI Is Feasible for Breast Screening

“This early evidence suggests that ULF MRI can detect essential breast features and some abnormalities without radiation or injected contrast,” ...

Breast imaging with an ultra-low field MRI scanner: a pilot ...

This preliminary work demonstrates that ULF breast MRI is feasible and may be a potential option for comfortable, widely deployable, and low- ...

Survival Outcomes of Screening with Breast MRI in Women at ...

Combined screening with MRI and mammography in women at elevated risk of breast cancer improves cancer detection and overall survival.

Breast Cancer Screening May Benefit from Ultra‑Low‑Field ...

The researchers noted that MRI can overcome some of limitations of mammography and is often the screening method of choice for high-risk ...