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Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varian Medical
ClinicalTrials.gov Identifier:
NCT01396551
First received: July 12, 2011
Last updated: February 3, 2017
Last verified: February 2017

July 12, 2011
February 3, 2017
October 2010
December 2016   (Final data collection date for primary outcome measure)
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.
Localization using the Calypso system. [ Time Frame: 1-2 weeks following implantation ]
The primary endpoint of localization will be assessed within approximately 1-2 weeks following implantation at the time radiation treatment is initiated and the ability to localize the target is confirmed. Additionally, participants will be followed for approximately one year after implantation for assessment of safety outcomes.
Complete list of historical versions of study NCT01396551 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
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Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Lung Cancer
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.
Experimental: Transponder implantation
Implantation of anchored Beacon transponder in the lung
Intervention: Device: Implantation of anchored Beacon transponder in the lung
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
January 2017
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   South Africa,   Switzerland
 
 
NCT01396551
CMT - 01-10
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Varian Medical
Varian Medical
Not Provided
Study Director: Lisa Levine, PhD Varian Medical Systems
Varian Medical
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP