Low-field MRI for Breast Cancer Screening

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05486520
Status
Enrolling By Invitation

Conditions

  • Breast Benign
  • Breast Malignant Tumor
  • Malignant Neoplasm of Breast

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Magnetic Resonance Imaging (MRI) — 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

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
May 2026
Primary completion
Sep 15, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

T1rho dispersion signal [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115-

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By research site
Massachusetts General Hospital· Boston, MA

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