An interventional study of NOVATECH® LUCIOLA™ EB - (Fiducial Marker) in Lung Cancer, sponsored by Hospital St. Joseph, Marseille, France. Status unknown at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-27.
Sponsored by Hospital St. Joseph, Marseille, France · Not applicable, Interventional, and Other
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.
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).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 35 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hospital St. Joseph, Marseille, France is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Time frame: Takes place 4-6 weeks after implantation
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Hospital St. Joseph, Marseille, France