Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transponder implantation Implantation of anchored Beacon transponder in the lung |
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.
|
Outcome Measures
Primary Outcome Measures
- To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders. [1-2 weeks following implantation]
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 [1-2 weeks following implantation]
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. [1-14 months, depending on the duration of radiotherapy and time between follow-up visits.]
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 [Time of implantation through the completion of the follow-up period of the study (0-14 months)]
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 [Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks]
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 [Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks]
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 [1-2 weeks following implantation]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Radiological Associates of Sacramento | Sacramento | California | United States | 95815 |
| 3 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 4 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 5 | New York University Langone Medical Center | New York | New York | United States | 10016 |
| 6 | Cancer Treatment Centers of America (CTCA) | Tulsa | Oklahoma | United States | 74133 |
| 7 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 8 | University of Heidelberg / Thoraxklinik / DKFZ | Heidelberg | Germany | ||
| 9 | Stellenbosch University / Tygerberg Hospital | Cape Town | South Africa | ||
| 10 | University Hospital Basel | Basel | Switzerland |
Sponsors and Collaborators
- Varian, a Siemens Healthineers Company
Investigators
- Study Director: Lisa Levine, PhD, Varian Medical Systems
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMT - 01-10
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Patients meeting inclusion/exclusion criteria and enrolled in the study were implanted with anchored transponders unless the patient's status changed prior to implantation. For example, if the patient's therapeutic plan was changed to exclude radiotherapy or the patient receives chest implants that preclude them from the study. |
| Arm/Group Title | Transponder Implantation |
|---|---|
| Arm/Group Description | 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. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy. |
| Period Title: Overall Study | |
| STARTED | 69 |
| COMPLETED | 69 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Transponder Implantation |
|---|---|
| Arm/Group Description | 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. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy. |
| Overall Participants | 69 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
65
|
| Sex: Female, Male (Count of Participants) | |
| Female |
37
53.6%
|
| Male |
32
46.4%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
41
59.4%
|
| South Africa |
10
14.5%
|
| Switzerland |
10
14.5%
|
| Germany |
8
11.6%
|
| Tumor characteristics (Count of Participants) | |
| Primary Lung |
55
79.7%
|
| Recurrent/second lung primary |
3
4.3%
|
| Metastatic to the lung |
11
15.9%
|
| Co-morbidities (Count of Participants) | |
| COPD |
46
66.7%
|
| other cardiac disease |
14
20.3%
|
| other pulmonary conditions |
13
18.8%
|
| Coronary Artery Bypass graft surgery |
5
7.2%
|
| Congestive heart failure |
4
5.8%
|
| Prior pneumothorax |
4
5.8%
|
| Angioplasty or coronary artery stenting |
3
4.3%
|
| Baseline symptoms (Count of Participants) | |
| Dyspnea |
39
56.5%
|
| Cough |
38
55.1%
|
| Sputum production |
24
34.8%
|
| Wheezing |
9
13%
|
| Hemoptysis |
3
4.3%
|
| Prior Thoracic Surgery (Count of Participants) | |
| Count of Participants [Participants] |
15
21.7%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two patients were not included in the analysis. One patient became ineligible for Calypso localization after receiving a pacemaker, and one patient did not undergo radiation therapy because of disease progression. |
| Arm/Group Title | Transponder Implantation |
|---|---|
| Arm/Group Description | 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. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy. |
| Measure Participants | 67 |
| Count of Participants [Participants] |
66
95.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Transponder Implantation | |
| Arm/Group Description | 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. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy. | |
All Cause Mortality |
||
| Transponder Implantation | ||
| Affected / at Risk (%) | # Events | |
| Total | 17/69 (24.6%) | |
Serious Adverse Events |
||
| Transponder Implantation | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/69 (10.1%) | |
| Cardiac disorders | ||
| anethesia induced short cardiac arrest | 1/69 (1.4%) | 1 |
| Infections and infestations | ||
| Contiguous Pneumonia | 1/69 (1.4%) | 1 |
| lung infection with pulmonary abcess and bronchopleural fistula | 1/69 (1.4%) | 1 |
| acute bronchopneumonia | 1/69 (1.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| consolidation on major fissure | 1/69 (1.4%) | 1 |
| pneumothorax | 2/69 (2.9%) | 2 |
| Vascular disorders | ||
| hypotension | 1/69 (1.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Transponder Implantation | ||
| Affected / at Risk (%) | # Events | |
| Total | 36/69 (52.2%) | |
| General disorders | ||
| sore throat | 9/69 (13%) | 9 |
| sputum production | 3/69 (4.3%) | 3 |
| wheezing | 2/69 (2.9%) | 2 |
| vomiting | 2/69 (2.9%) | 2 |
| fatigue | 4/69 (5.8%) | 4 |
| weakness | 1/69 (1.4%) | 1 |
| fever | 3/69 (4.3%) | 3 |
| nausea | 2/69 (2.9%) | 2 |
| headache | 1/69 (1.4%) | 1 |
| dry mouth | 1/69 (1.4%) | 1 |
| chills | 1/69 (1.4%) | 1 |
| neck pain | 1/69 (1.4%) | 1 |
| Product Issues | ||
| anchored transponder migration outside the lung | 1/69 (1.4%) | 1 |
| Renal and urinary disorders | ||
| urinary retention | 2/69 (2.9%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| atelectasis | 2/69 (2.9%) | 2 |
| imaging evidence of post obstructive pneumonia | 2/69 (2.9%) | 2 |
| hemoptysis | 10/69 (14.5%) | 10 |
| cough | 13/69 (18.8%) | 13 |
| chest pain | 1/69 (1.4%) | 1 |
| post extubation bronchospasm | 1/69 (1.4%) | 1 |
| excoriations in oropharynx | 1/69 (1.4%) | 1 |
| hypoxia | 1/69 (1.4%) | 1 |
| dyspnea on exertion | 2/69 (2.9%) | 2 |
| pulmonary edema | 2/69 (2.9%) | 2 |
| throat/chest tightness | 1/69 (1.4%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Julie Allen |
|---|---|
| Organization | Varian Medical Systems |
| Phone | 206-330-2605 |
| julie.allen@varian.com |
- CMT - 01-10