A Medical Device Daily

Accuray (Sunnyvale, California), which focuses on radiosurgery, said that the company is partnering with The University of TexasM. D. Anderson Cancer Center (Houston) to launch a prospective clinical study to compare treatment outcomes in early-stage operable lung cancer. Patients in the study will be randomly assigned to traditional surgery or CyberKnife robotic radiosurgery for their treatment.

“We feel the time is right to explore less invasive alternatives for early stage lung cancer patients,” said Jack Roth, MD, professor and Bud Johnson Clinical Distinguished Chair, Department of Thoracic & Cardiovascular Surgery at M. D. Anderson and the study’s principal investigator.

Sites from around the world will participate in this 1,200-patient study, with coordination and oversight by the M. D. Anderson team. The goal of the study is to compare treatment outcomes between surgery and CyberKnife radiosurgery across a broad range of geographic healthcare markets. Patient accrual is expected to begin in early 2008.

A major factor in the success of this study is selecting the most accurate method of treatment that will maximize radiation to the tumor and minimize damage to surrounding healthy tissue.

“Over the past five years clinicians have obtained excellent outcomes treating lung cancer with CyberKnife Radiosurgery,” said Omar Dawood, M.D., MPH, vice president of Clinical Development of Accuray Incorporated. “We believe the CyberKnife System’s unique ability to track tumor motion and deliver radiation accurately and non-invasively make it the ideal platform for this clinical study. We are excited about this partnership with M. D. Anderson, a leader in cancer treatment, and the huge benefits this study’s outcomes could have for patients with lung cancer.”

The CyberKnife Robotic Radiosurgery System is the world’s only robotic radiosurgery system designed to treat tumors anywhere in the body non- invasively and with sub-millimeter accuracy, the company said.

Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System is designed to track, detect and correct for tumor and patient movement in real-time throughout the treatment. That enables the CyberKnife System to deliver precise, high-dose radiation, minimizing damage to surrounding healthy tissue and eliminating the need for invasive head or body stabilization frames.

In other agreements news: Calypso Medical (Seattle) and Impac Medical Systems (Sunnyvale, California) have identified product collaboration projects which will further enable integration of oncology management systems with the Calypso 4-D localization system. Designed to provide an objective and continuous method to set up patients for radiation treatment, the Calypso system monitors the patient during treatment without adding ionizing radiation.

“Calypso Medical plans to work with Impac to provide our customers with innovative approaches to real-time organ motion management from patient setup through treatment,” said Eric Meier, president/CEO of Calypso. “We anticipate workflow gains that will further solidify our platform as ideal and unique by providing continuous and real-time target localization solutions.”

Precise setup, consistent delivery, and accurate treatment documentation are critical to radiation oncology. With this product collaboration, customers are expected to be able to more efficiently manage organ motion with the addition of new features such as the capability of remote table repositioning. Accurate and precise delivery of radiation treatment will be ensured by correcting for motion detected by the Calypso System prior to and during the actual treatment, according to the companies.