JPRN-jRCTs062200029招募中1 期
A prospective, single-center, single-arm, open label, feasibility study to evaluate safety and efficacy of MWA for unresectable lung cancer (SCIRO-2002) - SCIRO-2002
Tomita Koji0 个研究点目标入组 10 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1) Age of the patient 20 years old or older
- •2) Lung tumor is clinically diagnosed as NSCLC (include local tumor progression) or metastatic cancer
- •3) Refractory or unsuitable for surgical resection
- •4) Size of the target lesion smaller than 3.0 cm
- •5) Number of target lesion smaller than 3 in one lung and 6 in bilateral lung
- •6) On spirometry test, FEV1 is greater than 1.0 L and %VC is greater than 80%
- •7) No uncontrollable metastasis except on the lung
- •8) All of the following conditions are met
- •a) White blood-cell count >= 3000 /mm3
- •b) platelet count >= 50,000 /mm3
- •c) Hemogrobin >= 7.5 g/dl
- •d) Prothrombin time-international normalized ratio <= 1.5
排除标准
- •1)Absence of the safe needle insertion pathway
- •2)Presence of critical organ or vessel structures contact with target lesion
- •3)Active infectious desease except viral hapatitis
- •4)Active multiple cancers exept carcinoma in situ, intramucosal cancer, curative treated cancer, controlled breast cancer or prostate cancer
- •5)Interstitial pneumonia is observed on chest X-ray or CT imaging
- •6)Patients with cardiovascular implantable electronic devices
- •7)Patients receiving antiplatelet, thrombolytic, or anticoagulant drugs who are unable to stop the drug temporarily or replace it with heparin
- •8)Pregnant status
- •9)Inappropriateness of the candidate for the study judged by the investigators because of other reasons
研究者
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