Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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

Magnetic Resonance Imaging (MRI)

Matthew S Rosen, Ph.D

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.

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.

Low-field MRI for Breast Cancer Screening

A New Breast Cancer MRI Biomarker Using the Intrinsic T1rho Signal

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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).

National Institutes of Health (NIH)

Massachusetts General Hospital

Principal Investigator

Participants with dense breast tissue will get a mammogram and MRI

Breast MRI

State-of-the-art full-field digital mammography (FFDM) and or digital breast tomosynthesis (DBT) comprising both raw and post-processed images as well as ultrasound and MRI images from the initial screening study will be collected and sent to the MSKCC Breast Radiology Department.

Breast Mammogram

Participants will donate approximately 60ml of peripheral blood. Mononuclear cells from peripheral blood will be used to extract germline DNA. Germline genomic testing will be employed as a matched control for tumor sequencing and for germline breast cancer susceptibility testing.

Blood draw

Tissue specimens from the biopsy of the BI-RADS 4 mammographic lesion and (among women undergoing surgical excision) the surgical specimen(s) will be subjected to genomic profiling at GRAIL, Inc. or MSKCC. The tumor specimens from the participants diagnosed with cancer during the follow-up period will also undergo molecular profiling.

Breast Biopsy

Participants will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, genetic testing, personal, and family history of cancer.

online participant reported questionnaire

Katja Pinker-Domenig, MD, PhD

The purpose of this study is to collect blood and tissue to help develop tests that might be able to detect cancer earlier. The investigator will be collecting these samples and reviewing test results from participants who have had an area of concern found on breast imaging, as well as from participants who are scheduled to have a routine breast cancer screening mammogram.

Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening

MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions

result of the biopsy of the BIRADS 4 breast

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Low-field MRI for Breast Cancer Screening	NCT05486520	Breast Benign Malignant Neopl... Breast Malignan...	Magnetic Resona...	20 Years - 80 Years	Massachusetts General Hospital
Low-field MRI for Breast Cancer Screening	NCT05486520	Breast Benign Malignant Neopl... Breast Malignan...	Magnetic Resona...	20 Years - 80 Years	Massachusetts General Hospital
Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening	NCT03372902	Breast Cancer Breast Benign	Breast MRI Breast Mammogra... Blood draw Breast Biopsy online particip...	18 Years -	Memorial Sloan Kettering Cancer Center

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