Breast Cancer Clinical Trial
Official title:
Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
The role of fat in breast cancer development and growth has been studied extensively using body mass index, a measure of whole body fatness, and dietary fat intake in a number of epidemiological studies. However, there is a paucity of studies, on an individual level, to assess the role of breast fat itself in breast cancer due to lack of a non-invasive and fast measurement method. Since breast fibroglandular cells are surrounded by breast fat cells, the characteristics of breast fat may have a stronger relationship with breast cancer development, as supported by recent studies showing that a majority of breast cancer develops at the interface between fibroglandular tissue and adipose tissue. However, it is not trivial to study the role of breast fat, mainly due to the lack of a non-invasive and fast measurement method sensitive enough to important features of breast fat, such as types of fat.Recently, we have developed a rapid MRI method, referred to as Gradient-echo Spectroscopic Imaging (GSI), to measure fatty acid composition during clinical breast MRI exams. GSI can provide map of saturated fat and unsaturated fats in the breast adipose tissue without performing tissue biopsy. Our pilot study found that the postmenopausal women with aggressive breast cancer, known as invasive ductal carcinoma, have a significantly higher percentage of saturated fat in their breast adipose tissue than the postmenopausal women with only benign lesions.
Status | Recruiting |
Enrollment | 134 |
Est. completion date | January 23, 2025 |
Est. primary completion date | January 23, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 99 Years |
Eligibility | Inclusion Criteria: - No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet) - No contraindication to gadolinium contrast agent (severe renal insufficiency (EGFR<30), allergy to gadolinium) which will be injected for clinical exam - Able and willing to provide informed consent - Post-menopausal age > 25 years. Exclusion Criteria: - Contra-indication to MRI or gadolinium contrast agent (have a pacemaker, aneurysm clip, or other metallic implant; weigh >135 kg; or have renal impairment) - Breast surgery within prior 12 months, or breast implants - Any hormonal therapy |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare GSI-measured breast SFA fraction between women with malignant and benign lesions. | 5 Years |
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