Lung CancerNCT01396551
Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
A study testing Implantation of anchored Beacon transponder in the lung in people with Lung Cancer, run by Varian, a Siemens Healthineers Company at 10 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Implantation of anchored Beacon transponder in the lung
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Oct 2010to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35233
New York University Langone Medical Center
New York, New York, 10016
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Radiological Associates of Sacramento
Sacramento, California, 95815
Washington University
St Louis, Missouri, 63110
Cancer Treatment Centers of America (CTCA)
Tulsa, Oklahoma, 74133
South Africa1 site
Stellenbosch University / Tygerberg Hospital
Cape Town
About this study
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
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Implantation of anchored Beacon transponder in the lung
- Keywords
- Anchored Beacon Transponder, Anchored Transponder, Lung cancer, Calypso system, Realtime tracking
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of anchored Beacon transponder in the lungDevice
Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung.
| Study group | Role | What they receive |
|---|---|---|
| Transponder implantation | Experimental | Implantation of anchored Beacon transponder in the lung Receives: Device: Implantation of anchored Beacon transponder in the lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 weeks following implantation
Secondary outcomes (6)
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.
Measured: 1-2 weeks following implantation
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
Measured: 1-14 months, depending on the duration of radiotherapy and time between follow-up visits.
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.
Measured: Time of implantation through the completion of the follow-up period of the study (0-14 months)
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.
Measured: 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 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.
Measured: Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks
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.
Measured: 1-2 weeks following implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Levine, PhD, Study director, Varian Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396551
- Sponsor's protocol ID
- CMT - 01-10
- Status last verified
- Dec 2018
- First submitted
- 12 Jul 2011
- Last updated
- 2 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
- ClinicalTrials.gov ID
- NCT01396551
- Acronym / sponsor ID
- CMT - 01-10
- Conditions
- Lung Cancer
- Keywords
- Anchored Beacon Transponder, Anchored Transponder, Lung cancer, Calypso system, Realtime tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 2 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transponder implantation | Experimental | Device: Implantation of anchored Beacon transponder in the lungImplantation of anchored Beacon transponder in the lung |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of anchored Beacon transponder in the lungAnchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. | Device | Transponder implantation |
Primary outcome
To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
Time frame: 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.
6 secondary outcomes
To Assess the Implantation Procedure of the Anchored Transponder in the Lung
Time frame: 1-2 weeks following implantation
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.
Time frame: 1-14 months, depending on the duration of radiotherapy and time between follow-up visits.
To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure
Time frame: Time of implantation through the completion of the follow-up period of the study (0-14 months)
To Collect Target Localization and Tracking Data 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
To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data 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
To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume
Time frame: 1-2 weeks following implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Levine, PhD study director
Varian Medical Systems
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of anchored Beacon transponder in the lung in people with Lung Cancer, run by Varian, a Siemens Healthineers Company at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Germany, South Africa, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders. (time frame: 1-2 weeks following implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.