Trial record 1 of 1 for:
Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
This study is currently recruiting participants.
Verified August 2012 by Varian Medical
Sponsor:
Varian Medical
Information provided by (Responsible Party):
Varian Medical
ClinicalTrials.gov Identifier:
NCT01396551
First received: July 12, 2011
Last updated: August 31, 2012
Last verified: August 2012
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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: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (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 | Recruiting |
| Sacramento, California, United States, 95815 | |
| Contact: Tony Pu, MD PuT@radiological.com | |
| Principal Investigator: Tony Pu, MD | |
| United States, Florida | |
| 21st century Oncology | Recruiting |
| Fort Myers, Florida, United States, 33907 | |
| Contact: Rudi Ross rross@rtsx.com | |
| Principal Investigator: Constantine Mantz, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St.Louis, Missouri, United States | |
| Contact: Parag Parikh, MD pparikh@radonc.wustl.edu | |
| Principal Investigator: Parag Parikh, MD | |
| United States, Oklahoma | |
| Cancer Treatment Centers of America (CTCA) | Recruiting |
| Tulsa, Oklahoma, United States | |
| Contact: Daniel Nader, DO danielnader@sbcglobal.net | |
| Principal Investigator: Daniel Nader, DO | |
| Germany | |
| University of Heidelberg / Thoraxklinik / DKFZ | Recruiting |
| Heidelberg, Germany | |
| Contact: Felix Herth, MD, PhD Felix.Herth@thoraxklinik-heidelberg.de | |
| Principal Investigator: Felix Herth, MD, PhD | |
| South Africa | |
| Stellenbosch University / Tygerberg Hospital | Recruiting |
| Cape Town, South Africa | |
| Contact: Chris T Bolliger, MD ctb@sun.co.za | |
| Principal Investigator: Chris T Bolliger, MD | |
| Switzerland | |
| University Hospital Basel | Recruiting |
| Basel, Switzerland | |
| Contact: Frank Zimmerman, MD fzimmerman@uhbs.ch | |
| Principal Investigator: Frank Zimmerman, MD | |
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: | August 31, 2012 |
| 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 May 16, 2013