Phase one clinical trial of the use of focused ultrasound surgery for the treatment of soft-tissue tumors
Phase one clinical trial of the use of focused ultrasound surgery for the treatment of soft-tissue tumors
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使用聚焦超声手术治疗软组织肿瘤的一期临床试验
DOI：
10.1117/12.304353
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发表时间：
1998
期刊：
影响因子：
--
通讯作者：
A. Visioli
中科院分区：
文献类型：
--
作者：
G. ter Haar;I. Rivens;E. Moskovic;R. Huddart;A. Visioli
一个原型的体外皮质聚焦超声手术设备已经建立和测试广泛的模型系统在体内和体外。目前正在进行第一阶段的正常组织毒性试验。皮肤表面以下4 - 12 cm处有软组织肿瘤的患者正在使用剂量递增技术进行治疗。根据临床前研究确定了原位“消融强度”（AI）。发现在1.7 MHz下，这是1500 Wcm-2，持续长达3秒。三名患者的组以从25% AI上升至50%、63%、80%、100%至125% AI的剂量治疗1秒。最后，2和3秒暴露将用于两个最高剂量。患者不接受镇静或麻醉。靶点包括所有软组织肿瘤，特别是前列腺、肾脏和肝脏的肿瘤。检查患者的皮肤红斑，并要求患者在治疗前、治疗后立即、一周和一个月后完成疼痛和症状问卷。患者在暴露前和暴露后立即以及1周后接受诊断超声扫描。那些处于最高剂量水平的人也会接受磁共振扫描。
A prototype extra-corporeal focused ultrasound surgery device has been built and tested extensively in model systems both in vivo and ex vivo. A phase 1, normal tissue toxicity trial is now underway. Patients with soft tissue tumors lying 4 - 12 cm below the skin surface are being treated using a dose escalation technique. An in situ `ablative intensity' (AI) has been established from preclinical studies. This was found to be 1500 Wcm-2 for up to 3 seconds at 1.7 MHz. Groups of three patients are being treated at doses rising from 25% AI through 50%, 63%, 80%, 100% to 125% AI for 1 second. Finally, 2 and 3 second exposure will be used for the two highest doses. Patients receive no sedation or anaesthetic. Target sites include all soft tissue tumors, especially those of the prostate, kidney and liver. Patients are examined for skin erythema, and are asked to complete pain and symptom questionnaires prior to treatment, immediately after treatment, one week and one month later. Patients receive a diagnostic ultrasound scan before and immediately after exposure, and after 1 week. Those at the highest dose levels are also offered a magnetic resonance scan.