Lung Cancer
Conditions
Keywords
Anchored Beacon Transponder, Anchored Transponder, Lung cancer, Calypso system, Realtime tracking
Brief summary
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
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.
Interventions
DEVICEImplantation of anchored Beacon transponder in the lung
Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung.
Sponsors
Varian, a Siemens Healthineers Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders. | 1-2 weeks following implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1-14 months, depending on the duration of radiotherapy and time between follow-up visits. | 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 |
| To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure | Time of implantation through the completion of the follow-up period of the study (0-14 months) | 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. |
| To Assess the Implantation Procedure of the Anchored Transponder in the Lung | 1-2 weeks following implantation | 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. |
| To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data 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 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. |
| To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume | 1-2 weeks following implantation | 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. |
| To Collect Target Localization and Tracking Data 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 | Target localization and tracking data will be collected with the Calypso System during radiation treatment sessions. |
Countries
Germany, South Africa, Switzerland, United States
Participant flow
Pre-assignment details
Patients meeting inclusion/exclusion criteria and enrolled in the study were implanted with anchored transponders unless the patient's status changed prior to implantation. For example, if the patient's therapeutic plan was changed to exclude radiotherapy or the patient receives chest implants that preclude them from the study.
Participants by arm
| Arm | Count |
|---|---|
| Transponder Implantation Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy. | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | Transponder Implantation | — |
|---|---|---|
| Age, Continuous | 65 years | — |
| Baseline symptoms Cough | 38 Participants | — |
| Baseline symptoms Dyspnea | 39 Participants | — |
| Baseline symptoms Hemoptysis | 3 Participants | — |
| Baseline symptoms Sputum production | 24 Participants | — |
| Baseline symptoms Wheezing | 9 Participants | — |
| Co-morbidities Angioplasty or coronary artery stenting | 3 Participants | — |
| Co-morbidities Congestive heart failure | 4 Participants | — |
| Co-morbidities COPD | 46 Participants | — |
| Co-morbidities Coronary Artery Bypass graft surgery | 5 Participants | — |
| Co-morbidities other cardiac disease | 14 Participants | — |
| Co-morbidities other pulmonary conditions | 13 Participants | — |
| Co-morbidities Prior pneumothorax | 4 Participants | — |
| Prior Thoracic Surgery | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 8 participants | — |
| Region of Enrollment South Africa | 10 participants | — |
| Region of Enrollment Switzerland | 10 participants | — |
| Region of Enrollment United States | 41 participants | — |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 32 Participants | — |
| Tumor characteristics Metastatic to the lung | 11 Participants | — |
| Tumor characteristics Primary Lung | 55 Participants | — |
| Tumor characteristics Recurrent/second lung primary | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 69 |
| other Total, other adverse events | 36 / 69 |
| serious Total, serious adverse events | 7 / 69 |
Outcome results
Primary
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.
Time frame: 1-2 weeks following implantation
Population: Two patients were not included in the analysis. One patient became ineligible for Calypso localization after receiving a pacemaker, and one patient did not undergo radiation therapy because of disease progression.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transponder Implantation | To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders. | 66 Participants |
Secondary
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.
Time frame: 1-2 weeks following implantation
Secondary
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
Time frame: 1-14 months, depending on the duration of radiotherapy and time between follow-up visits.
Secondary
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.
Time frame: 1-2 weeks following implantation
Secondary
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.
Time frame: Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks
Secondary
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 frame: Time of implantation through the completion of the follow-up period of the study (0-14 months)
Secondary
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.
Time frame: Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks