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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roomila NAECK; Phone Number: +33 7 86 90 44 08; Email: luciola@hopital-saint-joseph.fr
• Study Contact Backup: Name: Rahamia AHAMADA; Phone Number: +33 4 88 73 10 71; Email: luciola@hopital-saint-joseph.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Centre de radiothérapie Francois Baclesse
    • Principal Investigator: Delphine LEROUGE, MD
    • Contact: Delphine Lerouge, MD; Phone Number: +33 2 31 45 50 20; Email: d.lerouge@baclesse.unicancer.fr
    • Contact: Tiphaine Plouhinec; Email: t.plouhinec@baclesse.unicancer.fr
  • Marseille, France, 13008
    • Recruiting
    • Hopital Saint Joseph
    • Contact: Roomila Naeck, PhD; Phone Number: + 33 (0)7 86 90 44 08; Email: Luciola@hopital-saint-joseph.fr
    • Contact: Rahamia Ahamada; Phone Number: + 33 (0)4 88 73 10 71; Email: Luciola@hopital-saint-joseph.fr
    • Principal Investigator: Bruno Escarguel, MD
  • Marseille, France, 13009
    • Recruiting
    • Hôpital Privé Clairval-Ramsay Santé
    • Contact: Jean-Baptiste Paoli, MD
    • Contact: Anne-Flore Cuvillier; Phone Number: +33 6.50.42.04.01; Email: cuvillier.af@outlook.fr
    • Principal Investigator: Jean-Baptiste Paoli, MD
  • Rouen, France, 76000
    • Recruiting
    • CHU Rouen
    • Principal Investigator: Samy LACHKAR, MD
    • Contact: Samy Lachkar, MD; Phone Number: +33 2 32 88 89 90; Email: samy.lachkar@chu-rouen.fr
    • Contact: Frédérique Gambu; Phone Number: +33 2 32 88 01 37; Email: frederique.gambu@chu-rouen.fr
  • Rouen, France, 76038
    • Recruiting
    • Centre de radiothérapie Henri Becquerel
    • Contact: Sébastien Thureau, MD; Phone Number: +33 2 32 08 29 92; Email: sebastien.thureau@chb.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France
• Collaborators: NOVATECH SA
• Investigators: Principal Investigator: Bruno Escarguel, MD, Hôpital Saint Joseph, Marseille France

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Bronchoscopy; Radiotherapy; SBRT; Fiducial marker; NOVATECH LUCIOLA EB
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LUCIOLA 2020_10_02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No