Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

The Calypso anchored lung transponders are a modified version of the previously FDA-cleared
Calypso soft tissue transponders. This modification includes an anchoring mechanism to hold
the transponder positionally stable within small airways of the lung. Transponders are placed
locally to the tumor within the lung and during subsequent radiotherapy the Calypso system
may be used to monitor the location of the transponders and, by extension, the tumor, in
real-time. This allows for improved tumor-targeting as well as gating of the radiation beam
when the tumor moves outside the target field during respiratory motion.

The goals of this investigation are to show that patients with implanted anchored
transponders can be localized with the Calypso System, that anchored transponder implantation
and use are feasible and safe, and that anchored transponders are positionally stable in the
small airways of patients with cancer of the lung.

Inclusion Criteria:

- Age ≥ 18 years at time of consent (19 years if required by local or state laws)

- 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 and who are expected to be able to
complete the full follow-up assessment in the protocol.

- 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. This will
require acquisition of a CT scan if a suitable one is not already available.

- 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 the Sponsor considers will interfere
with the Calypso System's electromagnetic localization (note that the Sponsor will
review a patient's implanted metal on a case by case basis).

- 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.

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