Clinical trial NCT01396551: Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Official title: Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Anchored Beacon Transponder
Anchored Transponder
Lung cancer
Calypso system
Realtime tracking
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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

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 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.

Primary outcomes:
measure: To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
timeFrame: 1-2 weeks following implantation
Secondary outcomes:
measure: To Assess the Implantation Procedure of the Anchored Transponder in the Lung
timeFrame: 1-2 weeks following implantation
measure: 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.
timeFrame: 1-14 months, depending on the duration of radiotherapy and time between follow-up visits.
measure: To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure
timeFrame: Time of implantation through the completion of the follow-up period of the study (0-14 months)
measure: To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions
timeFrame: Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks
measure: To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data During the Radiation Treatment Sessions
timeFrame: Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks
measure: To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume
timeFrame: 1-2 weeks following implantation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America (CTCA)
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Heidelberg
country: Germany
facility: University of Heidelberg / Thoraxklinik / DKFZ
city: Cape Town
country: South Africa
facility: Stellenbosch University / Tygerberg Hospital
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Varian Medical Systems
name: Lisa Levine, PhD
role: STUDY_DIRECTOR
References: