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临床试验/NCT03400215
NCT03400215进行中(未招募)不适用

Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2018年7月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
190
试验地点
1
主要终点
To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.

研究概览

简要总结

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.

详细描述

The overarching goal of this study is to determine the role of saturated fatty acid in breast cancer development and growth. In this proposal, GSI will be used for non-invasive in vivo measurement of saturated fat in the breast adipose tissue of postmenopausal women who undergo diagnostic breast MRI exams (Aims 1 and 2) or MRI-guided biopsy scans (Aim 3). The central hypotheses is that (i) the breast saturated fatty acid fraction measured by GSI is associated with the presence of malignant lesions in the breast and (ii) the breast saturated fatty acid fraction correlates positively with inflammation in the breast adipose tissue that may lead to increase in estrogen production in adipocytes.The proposed study will evaluate whether breast saturated fat is an independent risk factor for breast cancer, and whether it can provide additional diagnostic information to current clinical diagnostic exams. In addition, the proposed imaging measure of breast saturated fat can be used to assess the efficacy of any intervention to reduce cancer-related inflammation in the breast adipose tissue and to investigate the possible role of fatty acid composition in prevention and clinical management of breast cancer.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
25 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Breast cancer confirmed by biopsy

Active Comparator

Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy

干预措施: Diagnostic Breast Cancer Scan (Diagnostic Test)

Breast cancer confirmed by biopsy

Active Comparator

Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy

干预措施: Research Scan for Gradient-echo Spectroscopic Imaging (GSI) (Diagnostic Test)

Women without any history of breast cancer

Active Comparator

No known malignancy confirmed by at least 1-year follow up exams.

干预措施: Diagnostic Breast Cancer Scan (Diagnostic Test)

Women without any history of breast cancer

Active Comparator

No known malignancy confirmed by at least 1-year follow up exams.

干预措施: Research Scan for Gradient-echo Spectroscopic Imaging (GSI) (Diagnostic Test)

结局指标

主要结局

To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.

时间窗: 5 Years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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