Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luciola<br>Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment. | Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)<br>* Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate | 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. | Takes place 4-6 weeks after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luciola implant visibility | Average of the visibility rate (number of visible LUCIOLA implant arm(s) (0,1,2 or 3) compared to the total number of LUCIOLA implant arms (3)) for all the LUCIOLA implants for the entire radiotherapy treatment | From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry) | 
| Global migration rate | Number of LUCIOLA implants which have migrated between the beginning (dosimetry visit) and end of treatment follow-up (12 weeks after last radiotherapy session) in relation to the total number of LUCIOLA implants | Dosimetry CT-Scan takes place 2-4 weeks after implantation; End of treatment CT-Scan takes place 12 weeks after last radiotherapy session | 
| Adverse events | Occurrence rate of adverse or unexpected events which took place between implantation and up to 3 months following the RT treatment's end. | 4.5 to 6 months (from implantation to the end of participant's enrollment in the study) | 
| Replanning radiotherapy treatment | Replanning rate = Number of replanning versus total number of sessions for all of the participants. | During radiotherapy sessions (4-6 weeks after implantation) | 
| Radiotherapist's satisfaction | Number of participants for whom the radiotherapist is satisfied in relation to the total number of participants. | End of study visit: 12 weeks after last radiotherapy session | 
| Pulmonologist's satisfaction | Number of procedures at the end of which the pulmonologist is satisfied in relation to the total number of procedures The following questions will be considered: Easy introduction of the LUCIOLA delivery system in the guide sheath Easy placement (release) of the LUCIOLA device at the implantation site Change of the position after LUCIOLA implant release | Within 24 hours after implantation | 
| Tumoral response | Tumoral response rate according to RECIST criteria between the inclusion CT-Scan and the radiotherapy end of treatment CT-Scan. | Between the inclusion CT-Scan (8 weeks prior to implantation at the most) and the radiotherapy end of treatment CT-Scan (12 weeks after last RT session) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiducial marker, Bronchoscopy, SBRT, Radiotherapy, NOVATECH LUCIOLA EB