N/A
Completed N=69
Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Source: ClinicalTrials.gov NCT01396551 ↗Enrolled (actual)
69
Serious AEs
10.1%
Results posted
Jan 2019
Primary outcomePrimary: To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders. — 66 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders. |
66 | — |
| SECONDARY To Assess the Implantation Procedure of the Anchored Transponder in the Lung |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure |
— | — |
| SECONDARY To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions |
— | — |
| SECONDARY To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data During the Radiation Treatment Sessions |
— | — |
| SECONDARY To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01396551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.