Clinical trial · Interventional
Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
NCT01396551CI-TRIAL-00036311completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implantation of anchored Beacon transponder in the lung | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transponder implantation
- description
- Implantation of anchored Beacon transponder in the lung
- interventionNames
- Device: Implantation of anchored Beacon transponder in the lung
Primary outcomes (1)
- measure
- To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
- timeFrame
- 1-2 weeks following implantation
- 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.
Secondary outcomes (6)
- measure
- To Assess the Implantation Procedure of the Anchored Transponder in the Lung
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.