NCT02111681Completed
Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 9 Apr 2014
- Start date
- Apr 2014
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT02111681
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From Apr 2014 to the primary completion date, 1 Jul 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with clinically significant active infections.
- Patients with a history of hypersensitivity to nickel.
Lab values
- 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.
Other
- Patients unable to comply with instructions for DIBH
- Patients with bronchiectasis in the region of the intended implantation sites.
- 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 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering West Harrison Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.