Low-field MRI for Breast Cancer Screening

NCT ID: NCT05486520

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-09-01

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.

Conditions

Breast Benign; Malignant Neoplasm of Breast; Breast Malignant Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Magnetic Resonance Imaging (MRI)

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type: DEVICE

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

Interventions

Magnetic 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

Intervention Type: DEVICE

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.

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Matthew S. Rosen, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew S Rosen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

21-579

Identifier Type: -

Identifier Source: org_study_id