NCT06809946

Brief Summary

In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
24mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

January 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 17, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 30, 2025

Last Update Submit

March 24, 2026

Conditions

Pulmonary NeoplasmsLymph Node InvolvementLung NeoplasmsPulmonary Nodule

Keywords

Fluorescence molecular bronchoscopyBevacizumab-800CWNear-infrared fluorescence imagingMolecular imagingPulmonary nodule

Outcome Measures

Primary Outcomes (1)

  • Fluorescent signal of malignant lesion versus non-tumorous tissue.

    Comparison of the in vivo fluorescent signal of malignant lesion (pulmonary nodule or lymph node metastasis) versus non-tumorous tissue: The fluorescent signal will be assessed qualitatively (categorical data) and quantitatively (pulmonary nodule: by multi-diameter single fiber reflectance spectroscopy/single-fiber fluorescence spectroscopy (MDSFR/SFF), lymph node metastases: by ultrasound guided needle biopsy single-fiber fluorescence (USNB/SFF)).

    Assessed directly during the bronchoscopy procedure

Secondary Outcomes (3)

  • FLuorescence signal analyses

    Up to 1 year

  • Optimal dose of bevacizumab-800CW

    Up to 1 year

  • Safety of bevacizumab-800CW injection and fluorescence molecular imaging

    Up to 24 hours after the fluorescence molecular bronchoscopy

Study Arms (2)

Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg

EXPERIMENTAL
Drug: injection with 15 mg bevacizumab-800CW before bronchoscopy

Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg

EXPERIMENTAL
Drug: injection with 25 mg bevacizumab-800CW before bronchoscopy

Interventions

injection with 25 mg bevacizumab-800CW before bronchoscopyDRUG

Patients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.

Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg
injection with 15 mg bevacizumab-800CW before bronchoscopyDRUG

Patients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.

Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent prior to participation in the study.
  • Age ≥ 18 years.
  • Patient has at least one intrabronchial, near-to-airway located or peripheral pulmonary nodule - with or without pathological lymph nodes - which is considered malignant (independent of its primary origin).
  • Patient is considered fit to undergo a diagnostic and/or therapeutic bronchoscopy (with or without addition of virtual navigation and/or endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated) to obtain tumor material according to standard care protocols.

You may not qualify if:

  • History of infusion reactions to bevacizumab.
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
  • Pregnancy or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Frederike Bensch, MD, PhD

CONTACT

0031503610280f.bensch@umcg.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 5, 2025

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

August 17, 2028

Study Completion (Estimated)

August 17, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

NL(1)