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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCalypso Beacon Implantation

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 26, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: Memorial Sloan Kettering Cancer Center
Interventions being studied: Device: Calypso Beacon Implantation

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Memorial Sloan Kettering MonmouthMiddletown, New Jersey
Memorial Sloan Kettering CommackCommack, New York
Memorial Sloan Kettering West HarrisonHarrison, New York
Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 26, 2025. Always confirm current availability with the study team.

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