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

Lung Cancer Clinical Trial

— LUCIOLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068973
• Other study ID #: LUCIOLA 2020_10_02
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2023
• Source: Hospital St. Joseph, Marseille, France
• Contact: Roomila NAECK
• Phone: +33 7 86 90 44 08
• Email: luciola[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• NOVATECH® LUCIOLA™ EB - (Fiducial Marker)
Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker

Locations

Country	Name	City	State
France	Centre de radiothérapie Francois Baclesse	Caen
France	Hôpital Privé Clairval-Ramsay Santé	Marseille
France	Hopital Saint Joseph	Marseille
France	Centre de radiothérapie Henri Becquerel	Rouen
France	CHU Rouen	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France	NOVATECH SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)