Trial record 1 of 1 for:    Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
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Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Varian Medical
ClinicalTrials.gov Identifier:
NCT01396551
First received: July 12, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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:
  • Localization using the Calypso system. [ Time Frame: 1-2 weeks following implantation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years at time of consent
  • 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.
  • 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.
  • 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 Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
  • 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.
  • For clinical study sites in Germany only the following items are additional specific exclusion criteria:

    • Positive pregnancy test.
    • Patients requiring additional therapies for the lung, such as brachytherapy, electrosurgical procedures, cryoablation and laser vaporization as stated in the Precautions section in the Instructions for Use.
    • Patients in whom real-time tracking with the Calypso System is not expected to be possible due to patient size.
  • Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396551

Locations
United States, California
Radiological Associates of Sacramento
Sacramento, California, United States, 95815
United States, Florida
21st century Oncology
Fort Myers, Florida, United States, 33907
United States, Missouri
Washington University
St.Louis, Missouri, United States
United States, Oklahoma
Cancer Treatment Centers of America (CTCA)
Tulsa, Oklahoma, United States
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
  More Information

No publications provided

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: June 5, 2013
Health Authority: United States: Food and Drug Administration
South Africa: National Health Research Ethics Council
Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices

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 April 17, 2014