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.