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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 10
- Primary Endpoint
- LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate
Time Frame: Takes place 4-6 weeks after implantation
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.
Secondary Outcomes
- Pulmonologist's satisfaction(Within 24 hours after implantation)
- Luciola implant "visibility"(From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry))
- Adverse events(4.5 to 6 months (from implantation to the end of participant's enrollment in the study))
- Replanning radiotherapy treatment(During radiotherapy sessions (4-6 weeks after implantation))
- Radiotherapist's satisfaction(End of study visit: 12 weeks after last radiotherapy session)
- Tumoral response(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))
- Global migration rate(Dosimetry CT-Scan takes place 2-4 weeks after implantation; End of treatment CT-Scan takes place 12 weeks after last radiotherapy session)
Investigators
ESCARGUEL Bruno
Pulmonologist
Hospital St. Joseph, Marseille, France