Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

Study Overview
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Brief Summary
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Clinical study investigating the feasibility and safety of using an anchored Calypso transponder in the airways of the lung for real-time monitoring of tumor location during radiotherapy

Detailed Description
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The Calypso anchored lung transponders are a modified version of the previously FDA-cleared Calypso soft tissue transponders. This modification includes an anchoring mechanism to hold the transponder positionally stable within small airways of the lung. Transponders are placed locally to the tumor within the lung and during subsequent radiotherapy the Calypso system may be used to monitor the location of the transponders and, by extension, the tumor, in real-time. This allows for improved tumor-targeting as well as gating of the radiation beam when the tumor moves outside the target field during respiratory motion. The goals of this investigation are to show that patients with implanted anchored transponders can be localized with the Calypso System, that anchored transponder implantation and use are feasible and safe, and that anchored transponders are positionally stable in the small airways of patients with cancer of the lung.

Official Title
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Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Implantation of anchored Beacon transponder in the lung


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at time of consent (19 years if required by local or state laws) Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or cancer that is metastatic to the lung. Patients who are to receive 30 Gy or more of external beam radiation therapy. Patients who are able to tolerate flexible bronchoscopy. Patients with life expectancy of at least 12 months and who are expected to be able to complete the full follow-up assessment in the protocol. Patients for whom the physician is able to identify suitable implantation sites for the anchored transponders on a recent (within the past 8 weeks) CT scan. This will require acquisition of a CT scan if a suitable one is not already available. Patients who are able to comply with the protocol. Exclusion Criteria: Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which the Sponsor considers will interfere with the Calypso System's electromagnetic localization (note that the Sponsor will review a patient's implanted metal on a case by case basis). Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effect of the Calypso System operation on these devices is unknown. Patients with active infections. Patients with bronchiectasis in the lobe 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). 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 enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transponder implantation<br>Implantation of anchored Beacon transponder in the lung | Device: Implantation of anchored Beacon transponder in the lung<br>* Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders. | Whether a patient can be localized by the Calypso System using the anchored transponders will be determined during the first week (i.e., the first five fractions) of radiation therapy. | 1-2 weeks following implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Implantation Procedure of the Anchored Transponder in the Lung | The implantation procedure of the anchored transponder in the lung will be assessed with respect to a number of criteria: ability to implant transponders where intended, implanting physician's satisfaction with the process, and geometric configuration of the implanted transponders. | 1-2 weeks following implantation | 
| To Assess the Positional Stability of the Anchored Transponders Short Term Through the Completion of Radiotherapy and Long Term Through One Year of Follow-up. | The positional stability of the anchored transponder configuration will be assessed using changes in intertransponder distance. Inter-transponder distance will be calculated from CT scans acquired at treatment planning (baseline), 2-4 subsequent follow-up CT scans acquired during radiation therapy, and 4 follow-up CT scans taking place between 10-13 months post-radiotherapy | 1-14 months, depending on the duration of radiotherapy and time between follow-up visits. | 
| To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure | Adverse events associated with the anchored transponder and implantation procedure from the time of implantation through the completion of the follow-up period will be recorded and assessed. | Time of implantation through the completion of the follow-up period of the study (0-14 months) | 
| To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions | Target localization and tracking data will be collected with the Calypso System during radiation treatment sessions. | Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks | 
| To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data During the Radiation Treatment Sessions | To record usability data, including user intervention in response to the localization and tracking data (e.g., pausing the bean, patient re-alignment, etc.) during the radiation treatment sessions. | Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks | 
| To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume | To calculate the potential reduction in volume and dose of normal lung irradiated when routine institutional planning target volume margins are reduced to a margin of 0.5 cm circumferentially made possible by realtime localization and tracking of the tumor. This calculation will be done for a subset of the patients. | 1-2 weeks following implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anchored Beacon Transponder, Anchored Transponder, Lung cancer, Calypso system, Realtime tracking