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Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Anchored Beacon Transponder, Anchored Transponder, Lung cancer, Calypso system, Realtime tracking
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Implantation of anchored Beacon transponder in the lung
Type: Device
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Radiological Associates of Sacramento
Status: Recruiting
Contact: Anna Messer - 205-975-2880 - amesser@uabmc.edu
Sacramento, California, United States
21st century Oncology
Status: Completed
Fort Myers, Florida, United States
University of Michigan
Status: Completed
Ann Arbor, Michigan, United States
Washington University
Status: Recruiting
Contact: Mary Feng, MD - maryfeng@med.umich.edu
St.Louis, Missouri, United States
Cancer Treatment Centers of America (CTCA)
Status: Recruiting
Contact: Parag Parikh, MD - pparikh@radonc.wustl.edu
Tulsa, Oklahoma, United States
University of Pennsylvania
Status: Completed
Philadelphia, Pennsylvania, United States
University of Heidelberg / Thoraxklinik / DKFZ
Status: Recruiting
Contact: Sally McNulty, RN - 215-662-7720 - Sally.Mcnulty@uphs.upenn.edu
Heidelberg, Germany
Stellenbosch University / Tygerberg Hospital
Status: Completed
Cape Town, South Africa
University Hospital Basel
Status: Completed
Basel, Switzerland
Status: Completed
Start Date
October 2010
Completion Date
December 2016
Sponsors
Varian Medical
Source
Varian Medical
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page