Phase 1 clinical trial of the use of focused ultrasound surgery for the treatment of soft tissue tumours.

被引:17
作者
ter Haar, GR [1 ]
Rivens, IH [1 ]
Moskovic, E [1 ]
Huddart, R [1 ]
Visioli, AG [1 ]
机构
[1] Royal Marsden Hosp, Joint Dept Phys, Sutton SM2 5PT, Surrey, England
来源
SURGICAL APPLICATIONS OF ENERGY, PROCEEDINGS OF | 1998年 / 3249卷
关键词
ultrasound therapy; hyperthermia; cancer therapy;
D O I
10.1117/12.304353
中图分类号
R318 [生物医学工程];
学科分类号
0831 ;
摘要
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 tumours 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 exposures will be used for the two highest doses. Patients receive no sedation or anaesthetic. Target sites include all soft tissue tumours, 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.
引用
收藏
页码:270 / 276
页数:7
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