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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

• Registration Number: NCT05068973
• Lead Sponsor: Hospital St. Joseph, Marseille, France

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-06
• Study Start: 2021-11-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27
• Primary Completion: 2024-09-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Luciola	NOVATECH® LUCIOLA™ EB - (Fiducial Marker)	Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment.

Primary Outcome Measures

Name	Time	Method
LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate	Takes place 4-6 weeks after implantation	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 Outcome Measures

Name	Time	Method
Pulmonologist's satisfaction	Within 24 hours after implantation	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
Luciola implant "visibility"	From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry)	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
Adverse events	4.5 to 6 months (from implantation to the end of participant's enrollment in the study)	Occurrence rate of adverse or unexpected events which took place between implantation and up to 3 months following the RT treatment's end.
Replanning radiotherapy treatment	During radiotherapy sessions (4-6 weeks after implantation)	Replanning rate = Number of replanning versus total number of sessions for all of the participants.
Radiotherapist's satisfaction	End of study visit: 12 weeks after last radiotherapy session	Number of participants for whom the radiotherapist is "satisfied" in relation to the total number of participants.
Tumoral response	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)	Tumoral response rate according to RECIST criteria between the inclusion CT-Scan and the radiotherapy end of treatment CT-Scan.
Global migration rate	Dosimetry CT-Scan takes place 2-4 weeks after implantation; End of treatment CT-Scan takes place 12 weeks after last radiotherapy session	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

Trial Locations

Locations (5)

Centre de radiothérapie Francois Baclesse; 🇫🇷 Caen, France

Hopital Saint Joseph; 🇫🇷 Marseille, France

Hôpital Privé Clairval-Ramsay Santé; 🇫🇷 Marseille, France

CHU Rouen; 🇫🇷 Rouen, France

Centre de radiothérapie Henri Becquerel; 🇫🇷 Rouen, France