Calypso Medical Technologies has announced that the FDA granted Investigational Device Exemption approval for its international clinical study evaluation of real-time tracking of lung cancer tumors during radiation delivery.
During the study, investigators will implant three anchored Beacon transponders in patients’ lungs and use the Calypso System to track tumor location and movement during lung cancer radiation therapy. Patient enrollment is planned at Washington University in St. Louis and Cancer Treatment Centers of America in Tulsa, Oklahoma.
Seattle-based Calypso began the study in October 2010 at Tygerberg Hospital, affiliated with the University of Stellenbosch, in South Africa, located outside of Cape Town. The multi-center study is also underway at the University of Heidelberg in Germany, and the University Hospital Basel in Switzerland.
“There is a clear need for dose-escalation in curative radiation therapy for most patients suffering from locally confined early stage lung cancer,” Frank Zimmermann, MD, principal investigator and head of the department of radiation oncology at University Hospital Basel, said in a statement. “Ideal techniques allow the guidance of the highly focused beams in real-time in spite of the complexity and inconstancy of tumor motion in the lung. They may also enable higher dose therapy than has been possible with more conventional stereotactic techniques.”
Early data on the implantation of the electromagnetic transponders in lung cancer patients, and the use of the Calypso System for real-time tracking in these patients, will be presented at the American Society of Radiation Oncology (ASTRO) meeting in Miami.