Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
|Official Title:||Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy|
- To determine the proportion of patients who can be localized by the Calypso System using the anchored transponders. [ Time Frame: 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.
- To assess the implantation procedure of the anchored transponder in the lung [ Time Frame: 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 assess the positional stability of the anchored transponders short term through the completion of radiotherapy and long term through one year of follow-up. [ Time Frame: 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 Frame: 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 collect target localization and tracking data 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 ]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 [ Time Frame: 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 [ Time Frame: 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.
|Actual Study Start Date:||October 2010|
|Study Completion Date:||January 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Transponder implantation
Implantation of anchored Beacon transponder in the lung
Device: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396551
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|Radiological Associates of Sacramento|
|Sacramento, California, United States, 95815|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|New York University Langone Medical Center|
|New York, New York, United States, 10016|
|United States, Oklahoma|
|Cancer Treatment Centers of America (CTCA)|
|Tulsa, Oklahoma, United States, 74133|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Heidelberg / Thoraxklinik / DKFZ|
|Stellenbosch University / Tygerberg Hospital|
|Cape Town, South Africa|
|University Hospital Basel|
|Study Director:||Lisa Levine, PhD||Varian Medical Systems|