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

Hospital Saint Joseph

Status

Enrolling

Conditions

Lung Cancer

Treatments

Device: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

Study type

Interventional

Funder types

Other

Identifiers

NCT05068973

LUCIOLA 2020_10_02

Details and patient eligibility

About

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.

Full 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).

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)