Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 2, 2019 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Varian, a Siemens Healthineers Company
- Interventions being studied
- Device: Implantation of anchored Beacon transponder in the lung
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
- Radiological Associates of SacramentoSacramento, California
- University of MichiganAnn Arbor, Michigan
- Washington UniversitySt Louis, Missouri
- New York University Langone Medical CenterNew York, New York
- Cancer Treatment Centers of America (CTCA)Tulsa, Oklahoma
- University of PennsylvaniaPhiladelphia, Pennsylvania
- University of Heidelberg / Thoraxklinik / DKFZHeidelberg
- Stellenbosch University / Tygerberg HospitalCape Town
- University Hospital BaselBasel
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 2, 2019. Always confirm current availability with the study team.