Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

Inclusion Criteria:

- Age ≥ 18 years at time of consent

- Patients planning to undergo radiation therapy for primary or recurrent carcinomas of
the lung or cancer that is metastatic to the lung.

- Patients who are to receive 30 Gy or more of external beam radiation therapy.

- Patients who are able to tolerate flexible bronchoscopy.

- Patients with life expectancy of at least 12 months.

- Patients for whom the physician is able to identify suitable implantation sites for
the anchored transponders on a recent (within the past 8 weeks) CT scan.

- Patients who are able to comply with the protocol.

Exclusion Criteria:

- Patients with 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.

- Patients with active implanted devices, such as pacemakers, defibrillators, and drug
infusion pumps since the effect of the Calypso System operation on these devices is
unknown.

- Patients with active infections.

- Patients with bronchiectasis in the lobe of the intended implantation sites.

- Patients with a history of hypersensitivity to nickel.

- Patients whose lung tumors are being monitored with MR imaging (MR imaging of the
anchored transponders is safe but yields an image artifact around the anchored
transponders).

- Patients with any other medical condition or laboratory value that would, at the
discretion of the investigator, preclude the patient from participation in this
clinical study.

- For clinical study sites in Germany only the following items are additional specific
exclusion criteria:

- Positive pregnancy test.

- Patients requiring additional therapies for the lung, such as brachytherapy,
electrosurgical procedures, cryoablation and laser vaporization as stated in the
Precautions section in the Instructions for Use.

- Patients in whom real-time tracking with the Calypso System is not expected to
be possible due to patient size.

- Patients enrolled in any other clinical studies the investigator believes to be in
conflict with this investigation.