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Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of anchored Beacon transponder in the lung
Sponsored by
Varian, a Siemens Healthineers Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Anchored Beacon Transponder, Anchored Transponder, Lung cancer, Calypso system, Realtime tracking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Radiological Associates of Sacramento
  • University of Michigan
  • Washington University
  • New York University Langone Medical Center
  • Cancer Treatment Centers of America (CTCA)
  • University of Pennsylvania
  • University of Heidelberg / Thoraxklinik / DKFZ
  • Stellenbosch University / Tygerberg Hospital
  • University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transponder implantation

Arm Description

Implantation of anchored Beacon transponder in the lung

Outcomes

Primary Outcome Measures

To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
Whether a patient can be localized by the Calypso System using the anchored transponders will be determined during the first week (i.e., the first five fractions) of radiation therapy.

Secondary Outcome Measures

To Assess the Implantation Procedure of the Anchored Transponder in the Lung
The implantation procedure of the anchored transponder in the lung will be assessed with respect to a number of criteria: ability to implant transponders where intended, implanting physician's satisfaction with the process, and geometric configuration of the implanted transponders.
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.
The positional stability of the anchored transponder configuration will be assessed using changes in intertransponder distance. Inter-transponder distance will be calculated from CT scans acquired at treatment planning (baseline), 2-4 subsequent follow-up CT scans acquired during radiation therapy, and 4 follow-up CT scans taking place between 10-13 months post-radiotherapy
To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure
Adverse events associated with the anchored transponder and implantation procedure from the time of implantation through the completion of the follow-up period will be recorded and assessed.
To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions
Target localization and tracking data will be collected with the Calypso System during radiation treatment sessions.
To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data During the Radiation Treatment Sessions
To record usability data, including user intervention in response to the localization and tracking data (e.g., pausing the bean, patient re-alignment, etc.) during the radiation treatment sessions.
To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume
To calculate the potential reduction in volume and dose of normal lung irradiated when routine institutional planning target volume margins are reduced to a margin of 0.5 cm circumferentially made possible by realtime localization and tracking of the tumor. This calculation will be done for a subset of the patients.

Full Information

First Posted
July 12, 2011
Last Updated
December 10, 2018
Sponsor
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT01396551
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Anchored Beacon Transponder, Anchored Transponder, Lung cancer, Calypso system, Realtime tracking

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transponder implantation
Arm Type
Experimental
Arm Description
Implantation of anchored Beacon transponder in the lung
Intervention Type
Device
Intervention Name(s)
Implantation of anchored Beacon transponder in the lung
Intervention Description
Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung.
Primary Outcome Measure Information:
Title
To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
Description
Whether a patient can be localized by the Calypso System using the anchored transponders will be determined during the first week (i.e., the first five fractions) of radiation therapy.
Time Frame
1-2 weeks following implantation
Secondary Outcome Measure Information:
Title
To Assess the Implantation Procedure of the Anchored Transponder in the Lung
Description
The implantation procedure of the anchored transponder in the lung will be assessed with respect to a number of criteria: ability to implant transponders where intended, implanting physician's satisfaction with the process, and geometric configuration of the implanted transponders.
Time Frame
1-2 weeks following implantation
Title
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.
Description
The positional stability of the anchored transponder configuration will be assessed using changes in intertransponder distance. Inter-transponder distance will be calculated from CT scans acquired at treatment planning (baseline), 2-4 subsequent follow-up CT scans acquired during radiation therapy, and 4 follow-up CT scans taking place between 10-13 months post-radiotherapy
Time Frame
1-14 months, depending on the duration of radiotherapy and time between follow-up visits.
Title
To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure
Description
Adverse events associated with the anchored transponder and implantation procedure from the time of implantation through the completion of the follow-up period will be recorded and assessed.
Time Frame
Time of implantation through the completion of the follow-up period of the study (0-14 months)
Title
To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions
Description
Target localization and tracking data will be collected with the Calypso System during radiation treatment sessions.
Time Frame
Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks
Title
To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data During the Radiation Treatment Sessions
Description
To record usability data, including user intervention in response to the localization and tracking data (e.g., pausing the bean, patient re-alignment, etc.) during the radiation treatment sessions.
Time Frame
Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks
Title
To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume
Description
To calculate the potential reduction in volume and dose of normal lung irradiated when routine institutional planning target volume margins are reduced to a margin of 0.5 cm circumferentially made possible by realtime localization and tracking of the tumor. This calculation will be done for a subset of the patients.
Time Frame
1-2 weeks following implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Levine, PhD
Organizational Affiliation
Varian Medical Systems
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Radiological Associates of Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cancer Treatment Centers of America (CTCA)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Heidelberg / Thoraxklinik / DKFZ
City
Heidelberg
Country
Germany
Facility Name
Stellenbosch University / Tygerberg Hospital
City
Cape Town
Country
South Africa
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

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