NCT00373152撤回2 期
Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Complete Tumor Necrosis
研究概览
简要总结
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well radiofrequency ablation works to kill breast cancer cells and help doctors predict whether breast cancer cells remain after treatment.
PURPOSE: This phase II trial is studying how well MRI works in predicting tumor response after radiofrequency ablation in women with invasive breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine if radiofrequency ablation (RFA) can induce complete tumor necrosis in women with invasive breast cancer.
Secondary
- Determine whether breast MRI can accurately predict residual cancer and tumor necrosis in patients treated with RFA.
- Determine the toxicity of RFA in these patients.
- Determine the cosmetic outcome after RFA in these patients.
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
- •Diagnosis of invasive breast cancer - the following information must be known based on the needle core biopsy: tumor grade, hormone receptor status, and HER2/neu status. Patients with a previous history of either ipsilateral or contralateral excisional biopsy are not excluded. However, patients are excluded if an excisional biopsy was used to diagnose the current breast cancer.
- •Note: Subjects undergoing sentinel lymph node (SLN) biopsy will not be excluded from this research study. It is not expected that radiofrequency ablation (RFA) will interfere with the SLN procedure because other studies have demonstrated the accuracy of sentinel node staging after excisional biopsy. The axillary staging in these subjects will be noted.
- •Tumor size < 2 centimeters by mammogram or ultrasound, with ultrasound being the preferred method of evaluation. Measurements by physical exam should also be recorded. If mammogram and ultrasound are discordant, then the imaging modality that determines the largest tumor size will be used to determine eligibility.
- •Ultrasound measurements: Distance from tumor to skin must be > 1 cm; distance from tumor to chest wall must be > 1 cm. The RFA procedure, which burns the tumor, may also burn the skin or muscle if it is too close (< 1cm).
- •Laboratory values within 2 weeks of registration: platelet count ≥ 50,000; INR ≤ 1.6; serum creatinine ≤ 1.5 mg/dL; glomerular filtration rate (GFR) ≥ 60 ml/min/m^2
- •Age 18 years or older
- •Women must not be pregnant due to MR scanning of pregnant women is not FDA approved. All females of childbearing potential must have a urine study within 2 weeks prior to registration to rule out. Breast feeding must be discontinued prior to study entry.
排除标准
- •Subjects for whom neo-adjuvant therapy is planned will be excluded from this study
- •Patients with history of severe asthma and/or allergies will be excluded to avoid potential adverse reactions to the MRI contrast agent (Gd-DTPA)
- •Patients with pacemakers, any ferromagnetic implants or other ferromagnetic objects will be excluded
- •Patients with obesity (>250 pounds) will be excluded due to the limited diameter of the magnet bore tube
- •Patients with history of severe claustrophobia will be excluded
- •Patient must give written informed consent indicating the investigational nature of the study and its potential risks
结局指标
主要结局
Complete Tumor Necrosis
Efficacy of radiofrequency ablation (RFA) in inducing complete tumor necrosis as measured by immunohistochemical and biomarker studies.
次要结局
- Sensitivity and specificity of delayed dynamic contrast-enhanced MRI (DCE-MRI) in detecting residual cancer after RFA as measured by the Hylton method
- Cosmetic Outcome(after RFA but before definitive surgery)
- Toxicity or complications of RFA(before definitive surgery)
研究者
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