Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies

Inclusion Criteria:

Histologic proof of malignancy suitable for thoracic radiation therapy
Patient is planning to undergo radiation therapy for primary or recurrent malignancies of the lung or metastatic malignancies to the lung.
Age ≥ 18 years old
Karnofsky Performance Status ≥ 60%
At least part of the tumor must be visible as observed in a diagnostic or planning CT.
Able to have bronchoscopic placement of Calypso transponders as confirmed on a recent (within the past 8 weeks) CT scan.

Exclusion Criteria:

Patients with clinically significant active infections.
Bronchiectasis in the region of the intended implantation.
History of hypersensitivity to nickel.
Other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
Deemed unable to safely undergo or tolerate flexible bronchoscopy as per institutional guidelines
Unable to tolerate anesthesia or sedation
Enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
Female patients who are pregnant or nursing

Exclusion criteria for Calypso transponders:

Implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
Active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown.
Patients whose lung tumors are being monitored by MR imaging as part of standard clinical care. Implantation of transponders will degrade MR images.
Posterior lesions that would be >19 cm distance from Calypso detector plate.