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Trial Title:
Low-field MRI for Breast Cancer Screening
NCT ID:
NCT05486520
Condition:
Breast Benign
Malignant Neoplasm of Breast
Breast Malignant Tumor
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Conditions: Keywords:
Breast pathologies benign
Breast pathologies malignant
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Magnetic Resonance Imaging (MRI)
Description:
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
Arm group label:
BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS
Arm group label:
BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT
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.
Criteria for 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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Start date:
September 1, 2022
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05486520