NCT00107484已完成2 期
Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) using ferumoxtran-10, may help find and diagnose breast cancer that may have spread to the axillary lymph nodes and may help in planning breast cancer treatment.
PURPOSE: This phase II trial is studying how well MRI using ferumoxtran-10 works in finding metastases to the axillary lymph nodes in patients with invasive breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the utility of magnetic resonance (MR) imaging using ferumoxtran-10 in identifying metastases to the axillary lymph nodes in patients with invasive breast cancer.
Secondary
- Determine the changes in MR T1 and T2 signal intensity in primary breast tumors after administration of this drug to these patients.
- Determine the potential of delayed imaging, in terms of defining tumor boundaries, in these patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed invasive breast cancer
- •Candidate for sentinel lymph node biopsy and/or axillary lymph node dissection
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Ferritin ≤ 350 ng/mL*
- •Transferrin saturation level ≤ 40%* NOTE: *Patients with lab values above these limits may be eligible provided there is no hemochromatosis by hematology consultation
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Alkaline phosphatase normal
- •PT normal
- •Albumin normal
- •No history of cirrhosis
- •Creatinine normal OR
- •Creatinine clearance > 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Medically stable
- •No ongoing or active infection
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)
- •No history of allergic reaction to any contrast media
- •No immunodeficiency that would predispose patient to a specific or non-specific mediator release
- •No contraindication to MRI, including any of the following:
- •Severe claustrophobia
- •Pacemaker
- •Aneurysm clips
- •Defibrillators
- •Certain types of replacement joints
- •Other institutional contraindication to MRI
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
时间窗: 2 years
次要结局
- Changes in MR T1 and T2 signal intensity(2 years)
研究者
研究点 (1)
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