Beacon-Guided Breath-Hold radiation tested for lung cancer
NCT ID NCT02111681
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether small devices called Calypso beacons, placed near lung tumors, can help doctors track the tumor's position during radiation while the patient holds their breath. 48 adults with lung cancer took part. The goal was to see if this approach is feasible and to measure how much the tumor moves during treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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48 people
The number who actually took part.
- Started
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Apr 2014
- Finished
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Jul 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
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