Phase one clinical trial of the use of focused ultrasound surgery for the treatment of soft-tissue tumors

Gail R. ter Haar; Ian H. Rivens; Eleanor Moskovic; Robert Huddart; Andrew G. Visioli

doi:10.1117/12.304353

2 April 1998 Phase one clinical trial of the use of focused ultrasound surgery for the treatment of soft-tissue tumors

Gail R. ter Haar, Ian H. Rivens, Eleanor Moskovic, Robert Huddart, Andrew G. Visioli

Proceedings Volume 3249, Surgical Applications of Energy; (1998) https://doi.org/10.1117/12.304353
Event: BiOS '98 International Biomedical Optics Symposium, 1998, San Jose, CA, United States

Abstract

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.

Citation Download Citation

Gail R. ter Haar, Ian H. Rivens, Eleanor Moskovic, Robert Huddart, and Andrew G. Visioli "Phase one clinical trial of the use of focused ultrasound surgery for the treatment of soft-tissue tumors", Proc. SPIE 3249, Surgical Applications of Energy, (2 April 1998); https://doi.org/10.1117/12.304353

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