Lung CancerLUCIOLANCT05068973
Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients
A study testing NOVATECH® LUCIOLA™ EB - (Fiducial Marker) in people with Lung Cancer, run by Hospital St. Joseph, Marseille, France at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- NOVATECH® LUCIOLA™ EB - (Fiducial Marker)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesFrance
- Study dates
- 18 Nov 2021to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre de radiothérapie Francois Baclesse
Caen, 14000
Delphine Lerouge, MD, +33 2 31 45 50 20, d.lerouge@baclesse.unicancer.fr
Tiphaine Plouhinec, t.plouhinec@baclesse.unicancer.fr
- Recruiting
Hopital Saint Joseph
Marseille, 13008
Roomila Naeck, PhD, + 33 (0)7 86 90 44 08, Luciola@hopital-saint-joseph.fr
Rahamia Ahamada, + 33 (0)4 88 73 10 71, Luciola@hopital-saint-joseph.fr
- Recruiting
Hôpital Privé Clairval-Ramsay Santé
Marseille, 13009
Jean-Baptiste Paoli, MD
Anne-Flore Cuvillier, +33 6.50.42.04.01, cuvillier.af@outlook.fr
- Recruiting
CHU Rouen
Rouen, 76000
Samy Lachkar, MD, +33 2 32 88 89 90, samy.lachkar@chu-rouen.fr
Frédérique Gambu, +33 2 32 88 01 37, frederique.gambu@chu-rouen.fr
- Recruiting
Centre de radiothérapie Henri Becquerel
Rouen, 76038
Sébastien Thureau, MD, +33 2 32 08 29 92, sebastien.thureau@chb.unicancer.fr
Sébastien Thureau, MD
About this study
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
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.
Read the 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).
- Conditions
- Lung Cancer
- Being tested
- NOVATECH® LUCIOLA™ EB - (Fiducial Marker)
- Keywords
- Fiducial marker, Bronchoscopy, SBRT, Radiotherapy, NOVATECH LUCIOLA EB
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVATECH® LUCIOLA™ EB - (Fiducial Marker)Device
Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker
| Study group | Role | What they receive |
|---|---|---|
| Luciola | Experimental | Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment. Receives: Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Takes place 4-6 weeks after implantation
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start18 Nov 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Collaborators
- NOVATECH SA
- Responsible party
- Principal investigator, ESCARGUEL Bruno, Hospital St. Joseph, Marseille, France
- Investigators
- Bruno Escarguel, MD, Principal investigator, Hôpital Saint Joseph, Marseille France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068973
- Sponsor's protocol ID
- LUCIOLA 2020_10_02
- Acronym
- LUCIOLA
- Status last verified
- Jan 2023
- First submitted
- 20 Sep 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05068973
- Acronym / sponsor ID
- LUCIOLA / LUCIOLA 2020_10_02
- Conditions
- Lung Cancer
- Keywords
- Fiducial marker, Bronchoscopy, SBRT, Radiotherapy, NOVATECH LUCIOLA EB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Collaborators
- NOVATECH SA
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luciola | Experimental | Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVATECH® LUCIOLA™ EB - (Fiducial Marker)Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker | Device | Luciola |
Primary outcome
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.
7 secondary outcomes
Luciola implant "visibility"
Time frame: From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry)
Global migration rate
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
Time frame: 4.5 to 6 months (from implantation to the end of participant's enrollment in the study)
Replanning radiotherapy treatment
Time frame: During radiotherapy sessions (4-6 weeks after implantation)
Radiotherapist's satisfaction
Time frame: End of study visit: 12 weeks after last radiotherapy session
Pulmonologist's satisfaction
Time frame: Within 24 hours after implantation
Tumoral response
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Escarguel, MD principal investigator
Hôpital Saint Joseph, Marseille France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVATECH® LUCIOLA™ EB - (Fiducial Marker) in people with Lung Cancer, run by Hospital St. Joseph, Marseille, France at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roomila NAECK (+33 7 86 90 44 08, luciola@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate (time frame: Takes place 4-6 weeks after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.