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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 12, 2011
Last Updated Date	June 5, 2013
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 29, 2011)	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.
Original Primary Outcome Measures ^ICMJE (submitted: July 18, 2011)	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.
Change History	Complete list of historical versions of study NCT01396551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Official Title ^ICMJE	Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Lung Cancer
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	January 2014
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany, South Africa, Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01396551
Other Study ID Numbers ^ICMJE	CMT - 01-10
Has Data Monitoring Committee	Not Provided
Responsible Party	Varian Medical
Study Sponsor ^ICMJE	Varian Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Varian Medical
Verification Date	June 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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