Clinical trial · Interventional
Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients
Evaluation of the Performance and Tolerance of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Patients Suffering From Lung Cancer: Multicenter, Post CE-mark Study
- 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)
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.
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 |
|---|---|---|---|
| NOVATECH® LUCIOLA™ EB - (Fiducial Marker) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Luciola
- description
- Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment.
- interventionNames
- Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)
Primary outcomes (1)
- measure
- LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate
- timeFrame
- Takes place 4-6 weeks after implantation
- description
- Number of RT sessions during which the LUCIOLA implant was used for treatment in relation to the total number of RT sessions. If LUCIOLA can be detected and used for treatment, the patient will attend 3 to 5 RT sessions over a period lasting 1 to 2 weeks.
Secondary outcomes (7)
- measure
- Luciola implant "visibility"
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available