Overview
Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy.
At the time of insertion near the tumor, the Luciola's 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment.
Description
NOVATECH® LUCIOLA™ EB fiducial marker will be implanted near the lung tumor by bronchial endoscopy by a pulmonologist. Following a dosimetry visit, participants will be proposed a maximum of 5 radiation therapy sessions. A follow-up visit at 3 months will take place after the last radiotherapy session. The participation period for each participant will be between 4.5 and 6 months. This study will evaluate the Luciola implant's performance and safety (visibility, migration, complications, tumoral response).
Eligibility
Inclusion Criteria:
- Participants ≥ 18 years of age
- Participants with primary, secondary or metastatic lung cancer with an indication for radiotherapy and placement of a fiducial marker
- Participants who will be able to tolerate the flexible bronchoscopic implantation procedure and radiotherapy treatment.
- Participants who give their written informed consent
Exclusion Criteria:
- Participants with uncontrolled infection / participants with active infections.
- Participants with a bronchoscopy contra-indication
- Pregnant or breast-feeding women
- Participants with known allergy to one of the components (tantalum and nickel titanium alloy for the marker and polymer materials which are contained in the delivery device)