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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.

Lisa Levine, PhD

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

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.

Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

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.

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.

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

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.

Target localization and tracking data will be collected with the Calypso System during 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.

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.

Varian, a Siemens Healthineers Company

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.

Transponder Implantation

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

South Africa

Switzerland

Germany

Region of Enrollment

Primary Lung

Recurrent/second lung primary

Metastatic to the lung

Tumor characteristics

COPD

other cardiac disease

other pulmonary conditions

Coronary Artery Bypass graft surgery

Congestive heart failure

Prior pneumothorax

Angioplasty or coronary artery stenting

Co-morbidities

Dyspnea

Cough

Sputum production

Wheezing

Hemoptysis

Baseline symptoms

Prior Thoracic Surgery

Julie Allen

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.

To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.

To Assess the Implantation Procedure of the Anchored Transponder in the Lung

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.

Spots Global Cancer Trial Database for anchored transponder