Clinical trial NCT02111681: Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer
Official title: Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Calypso-based Deep Inspiration Breath Hold (DIBH)
radiation treatments
13-174
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2014-04-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients must have histologic proof of malignancy suitable for thoracic radiation therapy
* Patients planning to undergo radiation therapy for primary or recurrent malignancy of the lung or metastatic malignancy 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

Primary outcomes:
measure: feasibility of Calypso transponders
timeFrame: 2 years
Secondary outcomes:
measure: reproducibility
timeFrame: 2 years
measure: measure the residual intrafraction tumor motion
timeFrame: 2 years
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daphna Gelblum, MD
role: PRINCIPAL_INVESTIGATOR
References: