Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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

Key facts

Study ID

NCT01396551

Run by

Varian, a Siemens Healthineers Company

People needed

69

Starts

2010-10-01

Expected to finish

2017-01-01

Last updated by the study team

2019-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Radiological Associates of Sacramento — Sacramento, California, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• New York University Langone Medical Center — New York, New York, United States
• Cancer Treatment Centers of America (CTCA) — Tulsa, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Heidelberg / Thoraxklinik / DKFZ — Heidelberg, Germany
• Stellenbosch University / Tygerberg Hospital — Cape Town, South Africa
• University Hospital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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