NCT05068973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 18, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

September 20, 2021

Last Update Submit

January 26, 2023

Conditions

Lung Cancer

Keywords

Fiducial markerBronchoscopySBRTRadiotherapyNOVATECH LUCIOLA EB

Outcome Measures

Primary Outcomes (1)

  • 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.

    Takes place 4-6 weeks after implantation

Secondary Outcomes (7)

  • Luciola implant "visibility"

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

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Luciola

EXPERIMENTAL

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

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

Interventions

NOVATECH® LUCIOLA™ EB - (Fiducial Marker)DEVICE

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

Luciola

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre de radiothérapie Francois Baclesse

Caen, 14000, France

RECRUITING

Hopital Saint Joseph

Marseille, 13008, France

RECRUITING

Hôpital Privé Clairval-Ramsay Santé

Marseille, 13009, France

RECRUITING

CHU Rouen

Rouen, 76000, France

RECRUITING

Centre de radiothérapie Henri Becquerel

Rouen, 76038, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fiducial Markers

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reference StandardsWeights and MeasuresInvestigative TechniquesProstheses and ImplantsEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Bruno Escarguel, MD

    Hôpital Saint Joseph, Marseille France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roomila NAECK

CONTACT

+33 7 86 90 44 08luciola@hopital-saint-joseph.fr

Rahamia AHAMADA

CONTACT

+33 4 88 73 10 71luciola@hopital-saint-joseph.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pulmonologist

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 6, 2021

Study Start

November 18, 2021

Primary Completion

September 1, 2024

Study Completion

March 1, 2025

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

FR(5)