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Low-field MRI for Breast Cancer Screening | Clinical Trials | Clareo Health

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Low-field MRI for Breast Cancer Screening

A New Breast Cancer MRI Biomarker Using the Intrinsic T1rho Signal

NCT05486520•Massachusetts General Hospital

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.

Eligibility

Age

20 - 80 years

Sex

FEMALE

Healthy Volunteers

Yes

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

September 1, 2022

Primary Completion Date

October 15, 2023

Completion Date

September 1, 2024

Last Updated

September 21, 2023

Enrollment

ESTIMATED participants

Conditions

Breast BenignMalignant Neoplasm of BreastBreast Malignant Tumor

Interventions

Magnetic Resonance Imaging (MRI)

DEVICE

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

NCT07067138

Breast CancerBreast Carcinoma+2 more

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RECRUITINGPHASE1

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

NCT06878248

Breast Cancer MetastaticLocally Advanced Breast Cancer (LABC)+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Low-field MRI for Breast Cancer Screening

Inclusion Criteria

Exclusion Criteria

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery

Comparison of the Breast Tumor Microenvironment

Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer