Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

Status:	Recruiting
Conditions:	Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	12/6/2018
Start Date:	April 2014
End Date:	April 2020
Contact:	Andreas Rimner, MD
Phone:	212-639-6025

The purpose of this study is to test the use of Calypso beacon implants as a way to determine
where the lung tumor is located during radiation treatment. The Calypso beacons are small
devices that are implanted in the lungs, near the tumor. They are able to send a signal to a
tracking system to show where they are, and where the tumor is, as the patient holds their
breath for the radiation treatment. The investigators want to find out what effects, good
and/or bad, that this has on the patient and the way they treat the cancer in your lungs.

Inclusion Criteria:

- Patients must have histologic proof of malignancy suitable for thoracic radiation
therapy

- Patients planning to undergo radiation therapy for primary or recurrent carcinomas of
the lung or oligo-metastatic carcinoma to the lung.

- Age ≥ 18 years old

- KPS ≥ 60%

- Ability to hold their breath for >20 seconds for 5 times

- Patients who are able to tolerate flexible bronchoscopy

- Patients with life expectancy of at least 12 months

- Patients able to have bronchoscopic placement of Calypso as confirmed on a recent
(within the past 8 weeks) CT scan.

- Patients who are able to comply with the protocol follow-up schedule.

Exclusion Criteria:

- Patients unable to comply with instructions for DIBH

- 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 effects of the Calypso System operation on these devices are
unknown.

- Patients with clinically significant active infections.

- Patients with bronchiectasis in the region 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).

- Posterior lesions that would be >19cm distance from Calypso detector plate. Patients
may be treated in the prone position in order to meet the required minimum distance.

- 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 who are deemed unable to safely undergo or tolerate flexible bronchoscopy

- Patients who are unable to tolerate anesthesia or sedation

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

- Female patients who are pregnant or nursing

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000