NCT01062100已完成不适用
The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
Ontario Clinical Oncology Group (OCOG)1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
研究概览
简要总结
To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females ≥18 years of age
- •Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:
- •Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier
- •History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease)
- •History of Cowdens or Li Fraumeni Syndrome
- •A first degree relative with Cowdens or Li Fraumeni Syndrome
- •Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH)
- •Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator
排除标准
- •Pregnant or lactating
- •History of invasive breast cancer or ductal carcinoma in situ (DCIS)
- •Unable to undergo MRI because of:
- •Renal dysfunction with an estimated creatinine clearance of < 30 ml/min calculated using the Cockcroft-Gault formula
- •Implanted ferrous metal prostheses
- •Claustrophobia
- •Medical or psychological conditions that on assessment, make them unable to complete the procedure
- •Known allergies to Gadolinium-DTPA
- •Known allergies to Sestamibi (Miraluma or Cardiolite)
- •Prior bilateral mastectomy
- •Prior breast biopsy or surgery within 3 months
结局指标
主要结局
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
时间窗: 1 year
次要结局
- To explore the ability of the MBI Gamma camera to detect breast cancer.(1 year)
研究者
研究点 (1)
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