NCT01259076终止不适用
Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in BMI and breast density
研究概览
简要总结
Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.
详细描述
OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women eligible for gastric bypass surgery
- •Pre-menopausal women
- •All women will have signed an informed consent form prior to participating in study procedures
排除标准
- •Women with a history of breast cancer
- •Women currently taking exogenous hormone replacement therapy
- •Women currently taking a SERM
- •Women currently taking an aromatase inhibitor
- •Pregnant or lactating women
- •Women who have been pregnant or lactating in the past 2 years
- •Women who have metallic or other surgical implants
- •All subjects will have a determination of their estimated glomerular filtration rate (eGFR) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered
- •Subjects should not have a known history of recent onset acute renal dysfunction
- •Subjects with a history of stable chronic renal dysfunction may participate in studies using GBCA based on their eGFR, as outlined below
- •Subjects should not have severe liver dysfunction, particularly when associated with kidney disease
- •Subjects should receive GBCAs in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation
结局指标
主要结局
Change in BMI and breast density
时间窗: At baseline and year 1
次要结局
未报告次要终点
研究者
研究点 (1)
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