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

NCT ID: NCT05068973

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-18

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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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

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Luciola

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

Group Type EXPERIMENTAL

NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

Intervention Type DEVICE

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

Interventions

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NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NOVATECH SA

UNKNOWN

Sponsor Role collaborator

Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role lead

Responsible Party

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ESCARGUEL Bruno

Pulmonologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Escarguel, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Joseph, Marseille France

Locations

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Centre de radiothérapie Francois Baclesse

Caen, , France

Site Status RECRUITING

Hopital Saint Joseph

Marseille, , France

Site Status RECRUITING

Hôpital Privé Clairval-Ramsay Santé

Marseille, , France

Site Status RECRUITING

CHU Rouen

Rouen, , France

Site Status RECRUITING

Centre de radiothérapie Henri Becquerel

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Roomila NAECK

Role: CONTACT

+33 7 86 90 44 08

Rahamia AHAMADA

Role: CONTACT

+33 4 88 73 10 71

Facility Contacts

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Delphine Lerouge, MD

Role: primary

+33 2 31 45 50 20

Tiphaine Plouhinec

Role: backup

Roomila Naeck, PhD

Role: primary

+ 33 (0)7 86 90 44 08

Rahamia Ahamada

Role: backup

+ 33 (0)4 88 73 10 71

Jean-Baptiste Paoli, MD

Role: primary

Anne-Flore Cuvillier

Role: backup

+33 6.50.42.04.01

Samy Lachkar, MD

Role: primary

+33 2 32 88 89 90

Frédérique Gambu

Role: backup

+33 2 32 88 01 37

Sébastien Thureau, MD

Role: primary

+33 2 32 08 29 92

Other Identifiers

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LUCIOLA 2020_10_02

Identifier Type: -

Identifier Source: org_study_id

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