Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01396551
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01396551
Study Brief:
Protocol Section:
NCT01396551