Low-field MRI for Breast Cancer Screening

Not Applicable

• Conditions: Malignant Neoplasm of Breast; Breast Benign; Breast Malignant Tumor
• Interventions: Device: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT05486520
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-03
• Study Start: 2022-09-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-10-15
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT	Magnetic Resonance Imaging (MRI)	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.
BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS	Magnetic Resonance Imaging (MRI)	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.

Primary Outcome Measures

Name	Time	Method
T1rho dispersion signal	1 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).

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States