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Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients (LUCIOLA)

Primary Purpose

Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Fiducial marker, Bronchoscopy, SBRT, Radiotherapy, NOVATECH LUCIOLA EB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Centre de radiothérapie Francois BaclesseRecruiting
Hopital Saint JosephRecruiting
Hôpital Privé Clairval-Ramsay SantéRecruiting
CHU RouenRecruiting
Centre de radiothérapie Henri BecquerelRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Luciola

Arm Description

Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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.

Replanning radiotherapy treatment

Replanning rate = Number of replanning versus total number of sessions for all of the participants.

Radiotherapist's satisfaction

Number of participants for whom the radiotherapist is "satisfied" in relation to the total number of participants.

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

Tumoral response

Tumoral response rate according to RECIST criteria between the inclusion CT-Scan and the radiotherapy end of treatment CT-Scan.

Full Information

NCT ID

NCT05068973

First Posted

September 20, 2021

Last Updated

January 26, 2023

Sponsor

Hospital St. Joseph, Marseille, France

Collaborators

NOVATECH SA

1. Study Identification

Unique Protocol Identification Number

NCT05068973

Brief Title

Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients

Acronym

LUCIOLA

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 18, 2021 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital St. Joseph, Marseille, France

Collaborators

NOVATECH SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Fiducial marker, Bronchoscopy, SBRT, Radiotherapy, NOVATECH LUCIOLA EB

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Luciola

Arm Type

Experimental

Arm Description

Bronchoscopic implantation of the fiducial marker NOVATECH® LUCIOLA™ EB prior to radiotherapy treatment.

Intervention Type

Device

Intervention Name(s)

NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

Intervention Description

Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker

Primary Outcome Measure Information:

Title

LUCIOLA implant's performance during radiotherapy (RT) treatment: tracking rate

Description

Time Frame

Takes place 4-6 weeks after implantation

Secondary Outcome Measure Information:

Title

Luciola implant "visibility"

Description

Time Frame

From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry)

Title

Global migration rate

Description

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

Title

Adverse events

Description

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)

Title

Replanning radiotherapy treatment

Description

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)

Title

Radiotherapist's satisfaction

Description

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

Title

Pulmonologist's satisfaction

Description

Time Frame

Within 24 hours after implantation

Title

Tumoral response

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Roomila NAECK

Phone

+33 7 86 90 44 08

luciola@hopital-saint-joseph.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Rahamia AHAMADA

Phone

+33 4 88 73 10 71

luciola@hopital-saint-joseph.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno Escarguel, MD

Organizational Affiliation

Hôpital Saint Joseph, Marseille France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de radiothérapie Francois Baclesse

City

Caen

ZIP/Postal Code

14000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Delphine Lerouge, MD

Phone

+33 2 31 45 50 20

d.lerouge@baclesse.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Tiphaine Plouhinec

t.plouhinec@baclesse.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Delphine Lerouge, MD

Facility Name

Hopital Saint Joseph

City

Marseille

ZIP/Postal Code

13008

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roomila Naeck, PhD

Phone

+ 33 (0)7 86 90 44 08

Luciola@hopital-saint-joseph.fr

First Name & Middle Initial & Last Name & Degree

Rahamia Ahamada

Phone

+ 33 (0)4 88 73 10 71

Luciola@hopital-saint-joseph.fr

First Name & Middle Initial & Last Name & Degree

Bruno Escarguel, MD

Facility Name

Hôpital Privé Clairval-Ramsay Santé

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Baptiste Paoli, MD

First Name & Middle Initial & Last Name & Degree

Anne-Flore Cuvillier

Phone

+33 6.50.42.04.01

cuvillier.af@outlook.fr

First Name & Middle Initial & Last Name & Degree

Jean-Baptiste Paoli, MD

Facility Name

CHU Rouen

City

Rouen

ZIP/Postal Code

76000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samy Lachkar, MD

Phone

+33 2 32 88 89 90

samy.lachkar@chu-rouen.fr

First Name & Middle Initial & Last Name & Degree

Frédérique Gambu

Phone

+33 2 32 88 01 37

frederique.gambu@chu-rouen.fr

First Name & Middle Initial & Last Name & Degree

Samy Lachkar, MD

Facility Name

Centre de radiothérapie Henri Becquerel

City

Rouen

ZIP/Postal Code

76038

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sébastien Thureau, MD

Phone

+33 2 32 08 29 92

sebastien.thureau@chb.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Sébastien Thureau, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients

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