Beacon-Guided Breath-Hold radiation tested for lung cancer

NCT ID NCT02111681

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

48 people

The number who actually took part.

Started

Apr 2014

Finished

Jul 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering West Harrison

    Harrison, New York, 10604, United States

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