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

NCT02111681 | Completed Results

• 1 other identifier: 13-174
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Calypso-based Deep Inspiration Breath Hold (DIBH); radiation treatments; 13-174

Outcome Measures

Primary Outcomes (1)

• Feasibility of Calypso Transponders

  Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.

  2 years

Secondary Outcomes (2)

• Reproducibility

  2 years

• Measure the Residual Intrafraction Tumor Motion

  2 years

Study Arms (1)

Calypso-based Deep Inspiration Breath Hold (DIBH)

EXPERIMENTAL

This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies. Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest

Device: Calypso Beacon Implantation

Interventions

Calypso Beacon Implantation DEVICE

Bronchoscopic Calypso Beacon Implantation

Calypso-based Deep Inspiration Breath Hold (DIBH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (4)

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Daphna Gelblum, MD
• Organization: Memorial Sloan Kettering Cancer Center

gelblumd@mskcc.org

914-367-7273

Study Officials

• Daphna Gelblum, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2024-07

Locations

US (4)