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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Device: Calypso Beacon Implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calypso-based Deep Inspiration Breath Hold (DIBH)<br>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<br>* Bronchoscopic Calypso Beacon Implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of Calypso transponders | Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reproducibility | We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions. | 2 years | 
| measure the residual intrafraction tumor motion | will be measured in all 3 dimensions and the euclidean distance will be calculated, which will then be correlated with the normal tissue dosimetry by regression analysis. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calypso-based Deep Inspiration Breath Hold (DIBH), radiation treatments, 13-174