Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

Not Applicable

Completed

Conditions: Lung Cancer

Interventions: Device: Implantation of anchored Beacon transponder in the lung

Registration Number: NCT01396551

Lead Sponsor: Varian, a Siemens Healthineers Company

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transponder implantation	Implantation of anchored Beacon transponder in the lung	Implantation of anchored Beacon transponder in the lung

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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 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.

Trial Locations

Locations (10): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Radiological Associates of Sacramento
🇺🇸
Sacramento, California, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
New York University Langone Medical Center
🇺🇸
New York, New York, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Stellenbosch University / Tygerberg Hospital
🇿🇦
Cape Town, South Africa
University Hospital Basel
🇨🇭
Basel, Switzerland
University of Heidelberg / Thoraxklinik / DKFZ
🇩🇪
Heidelberg, Germany
Washington University
🇺🇸
Saint Louis, Missouri, United States
Cancer Treatment Centers of America (CTCA)
🇺🇸
Tulsa, Oklahoma, United States