NCT00774501已完成不适用
A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess safety & feasibility of single dose image-guided intensity modulated radio (IG-IMRT) using gen anesthesia with apneic oxygenation & controlled ventilation to temp suspend respiratory motion for tx of mets liver disease during localization & tx.
研究概览
简要总结
Liver tumors are hard to treat with radiation because the liver moves every time you breathe. The purpose of this study is to test a new and possibly more accurate way of treating liver tumors. When a person is asleep under anesthesia, it is safe to stop breathing motion for a while. The liver will stop moving and radiation can be given to a liver tumor. The study is being done to see if radiation can be given to liver tumors safely and accurately in this way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible to receive external beam intensity modulated radiotherapy for liver cancer
- •Age:21<80
- •KPS > or = to 80
- •Able to tolerate immobilization cradle positioning
- •Able to give informed consent
- •Histologically confirmed diagnosis of solid tumor malignancy
- •Liver metastases visualized on CT imaging (obtained within approximately 6 months from enrollment).
- •Target lesion ≤ or = to 8 cm in maximal diameter
- •In the case of multiple liver metastases, only one lesion will be targeted per treatment session. Typically the target lesion will be the lesion which is progressing or the cause of symptoms. The target lesion will be picked in consultation with the referring physician.
排除标准
- •Lymphoid primary histology (lymphoma/leukemia)
- •Single metastasis in an operable patient. Operable lesions will only be considered for enrollment in the protocol if the patient refuses resection of the metastasis.
- •Target lesion > 8 cm in maximal diameter
- •Cirrhosis of the liver (Child's C)
- •Liver function enzymes (AST, ALT) > 3x normal , obtained within 1 month of treatment.
- •< 500 cc uninvolved liver
- •Unable to tolerate intravenous CT contrast
- •Serum Hemoglobin < 9.0 (obtained within 1 month of treatment)
- •Presence of untreated brain metastases
- •Severe pulmonary disease (O2 dependent, unable to walk a flight of stairs)
- •Unstable cardiac status
- •Unstable angina
- •Significant abnormal 12 lead EKG (non sinus arrhythmia or ischemia unsuitable for general anesthesia)
- •Congestive Heart Failure
- •Abnormal kidney function (serum creatinine > 1.5) obtained within 1 month of treatment
- •Platelet count <70.
- •(obtained within 1 month of treatment).
- •INR > 2.0 (obtained within 1 month of treatment)
- •Marker seed placement not possible
- •Implanted defibrillator/pacemaker
- •Evidence of increased intracranial pressure
- •Significant ascites
- •Morbid Obesity
- •Pregnancy
结局指标
主要结局
To assess safety & feasibility of single dose image-guided intensity modulated radio (IG-IMRT) using gen anesthesia with apneic oxygenation & controlled ventilation to temp suspend respiratory motion for tx of mets liver disease during localization & tx.
时间窗: conclusion of study
次要结局
未报告次要终点
研究者
研究点 (1)
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