NCT00705497已完成1 期
Radiofrequency Ablation of Tumors (RFA) A Phase I Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- To determine the safety of RFA in patients with childhood acquired tumors
研究概览
简要总结
Background: This prospective study was designed to be the first to evaluate the toxicity of radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors.
Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for recurrent solid tumors. A multidisciplinary cancer management team selected appropriate candidates for the study. Imaging-guided RFA was performed percutaneously. Response was assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed malignancy (including aggressive fibromatosis) originally acquired during childhood (<21 years-of-age)
- •Patients who have undergone previous RFA may be enrolled again (different disease site) or receive subsequent ablation (same disease site) as long as the eligibility criteria are met at the time of re-enrollment, or a second ablation on study.
- •The subject is medically appropriate for the study as determined by a consensus of professionals at multidisciplinary tumor conference prior to enrollment. This discussion will be documented in the chart of the potential subject to be recruited for this study.
- •Histopathological material is available prior to the RF ablation except in patients with obvious tumor recurrence.
- •No Pacemakers or Automatic Implantable Cardioverter/Defibrillators (AICDs)
- •No tissue burns anticipated from implanted metal
- •Normal renal function (Creatinine < 2mg/dL)
- •Absolute neutrophil count (ANC) > 1000/cu.mm.
- •No uncorrectable coagulopathy (INR>1.5, PTT and PT > 1.5 x the upper limit of normal)
- •No uncorrectable thrombocytopenia (platelet count < 50,000/mm3)
- •Life expectancy over 30 days
- •RF ablation targets in the liver, lung or musculoskeletal system that meet the following criteria:
- •Hepatic lesions
- •Intrahepatic metastases not amenable to other therapy
- •Primary hepatic tumor if RF ablation of a portion of the tumor can lead to primary tumor resection rather than hepatic transplantation
- •Single primary or multiple tumors in the liver
- •At least one over 0.5 cm in diameter
- •Edge of lesion not contiguous with main hepatic or common biliary duct.
- •Musculoskeletal lesions
- •Local or regional recurrence of primary bone or soft tissue tumor not amenable to resection or radiotherapy
- •Osseous, soft tissue or lymph node metastases not amenable to resection or radiotherapy.
- •Head, neck, spine, extremity, chest wall, flank, abdominal wall, or pelvic bone or girdle lesions are treatable under this protocol
- •RFA target < 50% of axial area in weight bearing bone unless reinforced with internal fixation (bone cement infusion) or in non-ambulatory patient.
- •Lung lesions
- •No supplemental oxygenation is required.
- •Metastatic solid tumor that has recurred or progressed after primary thoracotomy or thoracoscopic removal that is not amenable to radiotherapy, surgery or chemotherapy
- •In the investigator's opinion, no supplemental oxygen will likely be required at rest for more than 30 days after RF ablation.
- •Tumor burden < 20% of lung volume
排除标准
- 未提供
结局指标
主要结局
To determine the safety of RFA in patients with childhood acquired tumors
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (2)
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