The US Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for Calypso Medical’s clinical study evaluating Calypso systems’ viability to precisely track lung cancer tumours during radiation therapy.
Utilising miniaturised, non-ionising implanted devices called beacon electromagnetic transponders, the Calypso system continuously and accurately tracks the location of cancerous tumours.
Patient enrollment in the study is planned at Washington University in St. Louis and the Cancer Treatment Centers of America in Tulsa, Oklahoma, US.
University Hospital Basel, Switzerland, Department of Radiation Oncology head Frank Zimmermann said the anchored beacon transponders used by the Calypso System provide them with immediate and precise information regarding the location and movement of tumours, which may help make radiation a feasible curative option for a broader group of patients suffering from lung cancer.
Southwestern Regional Medical Center Cancer Treatment Centers of America interventional pulmonologist Daniel Nader said the clinical study is to assess the clinical experience and safety of anchored transponders in the small airways of patients with lung cancer.
The US Food and Drug Administration previously cleared beacon transponders, for permanent implantation in the prostate and prostatic bed to provide precise, continuous information on the tumour location during radiation therapy.