Clinical trial NCT05068973: Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Fiducial marker
Bronchoscopy
SBRT
Radiotherapy
NOVATECH LUCIOLA EB
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
Collaborators: name: NOVATECH SA
First posted: 2021-10-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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 outcomes:
measure: LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate
timeFrame: Takes place 4-6 weeks after implantation
Secondary outcomes:
measure: Luciola implant "visibility"
timeFrame: From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry)
measure: Global migration rate
timeFrame: Dosimetry CT-Scan takes place 2-4 weeks after implantation; End of treatment CT-Scan takes place 12 weeks after last radiotherapy session
measure: Adverse events
timeFrame: 4.5 to 6 months (from implantation to the end of participant's enrollment in the study)
measure: Replanning radiotherapy treatment
timeFrame: During radiotherapy sessions (4-6 weeks after implantation)
measure: Radiotherapist's satisfaction
timeFrame: End of study visit: 12 weeks after last radiotherapy session
measure: Pulmonologist's satisfaction
timeFrame: Within 24 hours after implantation
measure: Tumoral response
timeFrame: 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)
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre de radiothérapie Francois Baclesse
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Marseille
country: France
facility: Hôpital Privé Clairval-Ramsay Santé
city: Rouen
country: France
facility: CHU Rouen
city: Rouen
country: France
facility: Centre de radiothérapie Henri Becquerel
Study officials:
affiliation: Hôpital Saint Joseph, Marseille France
name: Bruno Escarguel, MD
role: PRINCIPAL_INVESTIGATOR
References: