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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: May 19, 2017
Last verified: May 2017
  Purpose
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

Condition Intervention
Lung Cancer Device: Implantation of anchored Beacon transponder in the lung

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Varian Medical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 69
Actual Study Start Date: October 2010
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396551

Locations
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
Washington University
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
Germany
University of Heidelberg / Thoraxklinik / DKFZ
Heidelberg, Germany
South Africa
Stellenbosch University / Tygerberg Hospital
Cape Town, South Africa
Switzerland
University Hospital Basel
Basel, Switzerland
Sponsors and Collaborators
Varian Medical
Investigators
Study Director: Lisa Levine, PhD Varian Medical Systems
  More Information

Responsible Party: Varian Medical
ClinicalTrials.gov Identifier: NCT01396551     History of Changes
Other Study ID Numbers: CMT - 01-10
Study First Received: July 12, 2011
Last Updated: May 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Varian Medical:
Anchored Beacon Transponder
Anchored Transponder
Lung cancer
Calypso system
Realtime tracking

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2017