Non-invasive CyberKnife technology successfully tested in lung tumour therapy with image-guided radio-surgery

Sunnyvale 27 June 2001Both at the Cleveland Clinic Foundation and Stanford University Medical Center, the first twenty-five lung tumour patients have successfully been treated using non-invasive CyberKnife ablation technology. CyberKnife is developed by Accuray Incorporated, an expert in advanced image-guided radio-surgery, in co-operation with Stanford University. The unique system technology was cleared by the Food and Drug Administration (FDA) in 1999 for head, neck, and spine treatment to the cervico-thoracic junction. The new procedure is currently performed under IDE or Investigational Device Exemption, on patients with non-resectable lung tumours, and is carried out without anaesthesia on an outpatient basis.

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The CyberKnife technology utilises a robotic arm to deliver high doses of radiation that are generated from a miniature linear accelerator. A proprietary image-guidance system allows real time target tracking in order to compensate for natural tumour movement due to respiration, resulting in superior accuracy in radiation delivery. Dr. Richard Whyte, M.D., Associate Professor and Head of the Division of Thoracic Surgery at Stanford University Medical Center, stated: "The CyberKnife provides a unique treatment option for certain lung tumours. The early results of single fraction radio-surgery look quite encouraging."

Dr. Richard Crownover, M.D., Ph.D., Radiation Oncologist at the Cleveland Clinic Foundation and Principal Investigator of the CCF lung protocol, noted: "In the past, lung movement hampered conventional radiation delivery. New modifications enable the CyberKnife to track tumour motion so that a higher dose of radiation can be administered to the patient with minimal toxicity to surrounding tissue. Delivering higher doses of radiation increases the chance to cure small primary lung tumours." As Dr. Crownover continued: "For the palliation of metastatic disease, the decreased morbidity of radio-surgery compared with conventional radiation allows us to shift the time of intervention forward, before symptoms interfere with the quality of life."

The Cleveland Clinic Foundation, founded in 1921, integrates clinical and hospital care with research and education in a private, not-for-profit group practice. Approximately 1100 full-time salaried physicians at the Cleveland Clinic Foundation and Cleveland Clinic Florida represent more than 100 medical specialities and sub-specialities. Stanford University Medical Center integrates research, medical education, as well as patient care at its three institutions: Stanford University School of Medicine, Stanford Hospital and Clinics, and Lucile Packard Children's Hospital.

Dr. John Adler, M.D., founder and CEO of Accuray, concluded: "Radio-surgery for moving targets has been our goal and vision, so it is very exciting to see our work come to fruition. The potential to treat tumours anywhere in the patient's body accurately with radio-surgery is becoming a reality. We look forward to ongoing radio-surgical treatments in the lung, as well as for additional sites within the body, such as the prostate." The Accuray Company designs, manufactures, and distributes the CyberKnife radio-surgery systems in the USA and certain markets internationally. Accuray has as its mission to enable full-body radio-surgery using image-guided robotics and to make this technology available to physicians throughout the world.

At present, the CyberKnife is applied under the FDA Investigational Device Exemption (IDE) protocols for treating the spine below the cervico-thoracic junction, as well as the lung, prostate, and pancreas. The FDA 510(k) pre-market notification for the treatment of lesions anywhere in the body where radiation is indicated, is still pending. Currently, the CyberKnife is cleared only for head, neck, and cervical spine tumour treatments but these cases represent only a small portion of new tumours that are diagnosed each year.


Leslie Versweyveld

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