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| Name | Class |
|---|---|
| NOVATECH SA | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luciola | Experimental | Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOVATECH® LUCIOLA™ EB - (Fiducial Marker) | Device | Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roomila NAECK | Contact | +33 7 86 90 44 08 | luciola@hopital-saint-joseph.fr | |
| Rahamia AHAMADA | Contact | +33 4 88 73 10 71 | luciola@hopital-saint-joseph.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Escarguel, MD | Hôpital Saint Joseph, Marseille France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de radiothérapie Francois Baclesse | Recruiting | Caen | 14000 | France |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057918 | Fiducial Markers |
| ID | Term |
|---|---|
| D012015 | Reference Standards |
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
| D019736 | Prostheses and Implants |
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| 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:
| 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) |
| Hopital Saint Joseph | Recruiting | Marseille | 13008 | France |
|
| Hôpital Privé Clairval-Ramsay Santé | Recruiting | Marseille | 13009 | France |
|
| CHU Rouen | Recruiting | Rouen | 76000 | France |
|
| Centre de radiothérapie Henri Becquerel | Recruiting | Rouen | 76038 | France |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |