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ClinicalTrials.gov ID

NCT05068973

Lead Sponsor

Hospital St. Joseph, Marseille, FranceOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

35Estimated

Last Update Posted

Jan 27, 2023Actual

Start Date

Nov 18, 2021Actual

Primary Completion Date

Sep 1, 2024Estimated

Completion Date

Mar 1, 2025Estimated

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

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).

• Lung Cancer

• NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Hospital St. Joseph, Marseille, FranceOTHER

Collaborators

NOVATECH SAUNKNOWN

samy.lachkar@chu-rouen.fr+33 2 32 88 89 90