NCT06505642

Brief Summary

The goal of this proof of principle observational study is to investigate in patients with suspected peripheral pulmonary nodules. The main question it aims to answer is: • What is the concordance between CBCT navigation success (tool-in-lesion on CBCT spin) and nCLE tool-in-lesion confirmation (tool-in-lesion nCLE criteria observed). Participants scheduled to undergo a diagnostic conebeam navigation bronchoscopy will be included in the study. nCLE imaging at the tip of the TBNA needle will be added to the procedure for study purposes. Two needle punctures of the pulmonary nodule will be followed by nCLE imaging directly followed by a tool-in-lesion CBCT spin in order to compare nCLE results with CBCT results.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 8, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 13, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

July 11, 2024

Last Update Submit

November 11, 2024

Conditions

Lung NeoplasmPeripheral Lung Parenchyma TumorLung Cancer

Keywords

Confocal Laser EndomicroscopyBronchoscopyCone beam computed tomographyImage guided bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • CBCT navigation success and nCLE tool-in-lesion confirmation

    CBCT-NB navigation success: tool-in-lesion OR unsuccessful navigation nCLE tool-in-lesion confirmation: in-lesion nCLE criteria seen

    Intra-procedure

Secondary Outcomes (7)

  • Technical feasibility

    Intra-procedure

  • Safety

    Up to 7 days post procedure

  • Diagnostic yield

    up to 6 months post procedure

  • Diagnostic sensitivity for malignancy

    up to 6 months post procedure

  • Sensitivity, specificity and accuracy of real-time nCLE imaging assessment

    Intra-procedure

  • +2 more secondary outcomes

Other Outcomes (1)

  • Total procedure duration

    Intra-procedure

Study Arms (1)

nCLE + CBCT-NB

EXPERIMENTAL

Patients with a suspected malignant peripheral pulmonary nodule(s) referred for cone beam ct navigation bronchoscopy for tissue sampling.

Device: needle-based confocal laser endomicroscopy

Interventions

needle-based confocal laser endomicroscopyDEVICE

needle-based confocal laser endomicroscopy at the tip of the TBNA needle for two punctures, combined with confirmatory CBCT spin for tool-in-lesion confirmation

Also known as: cone beam computed tomography navigation bronchoscopy
nCLE + CBCT-NB

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Suspected pulmonary nodule with an indication for CBCT-NB (decided by multidisciplinary tumour board)
  • Nodule must be solid or partially solid
  • Solid part of the nodule must be at least 8 mm
  • Largest dimension of the nodule on CT equal or less than 30 mm
  • Ability to understand and willingness to sign a written informed consent

You may not qualify if:

  • Inability or non-willingness to provide informed consent
  • Patients with an endobronchial visible lung tumor on bronchoscopic inspection
  • Patients in which the target lesion is within reach of the linear EBUS scope
  • Lung nodules that resolved at the time of index intraprocedural CBCT
  • Failure to comply with the study protocol
  • Patients with known allergy for fluorescein or risk factors for an allergic reaction
  • Pregnant or breastfeeding women
  • Patients with hemodynamic instability
  • Patients with refractory hypoxemia
  • Patients with a therapeutic anticoagulant that cannot be held for an appropriate in-terval before the procedure
  • Patients who are unable to tolerate general anesthesia according to the anesthesiologist
  • Patient undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g. doxorubicin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jouke Annema, MD, PhD

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jouke Annema, MD, PhD

CONTACT

+31(0)20 566 2694j.t.annema@amsterdamumc.nl

Saskia van Heumen, MSc

CONTACT

+31(0)20 566 2694s.vanheumen@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Jouke Annema

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 17, 2024

Study Start

October 8, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

November 13, 2024

Record last verified: 2024-08

Locations

NL(1)