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Clinical Trials in the Netherlands / NCT06809946
Starting soon Phase 2

Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy

NCT06809946 · tracked via the Priya Life Science Netherlands tracker
Sponsor
University Medical Center Groningen
Phase
Phase 2
Started
2026-08-17
Last updated
2026-03-30

Condition(s) studied

Lung NeoplasmsPulmonary NeoplasmsLymph Node InvolvementPulmonary Nodule

Investigational drug(s) / intervention(s)

injection with 15 mg bevacizumab-800CW before bronchoscopyinjection with 25 mg bevacizumab-800CW before bronchoscopy

injection with 15 mg bevacizumab-800CW before bronchoscopy: 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.

injection with 25 mg bevacizumab-800CW before bronchoscopy: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent prior to participation in the study. 2. Age ≥ 18 years. 3. 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). 4. 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. Exclusion Criteria: 1. History of infusion reactions to bevacizumab. 2. Medical or psychiatric conditions that compromise the patient's ability to give informed consent. 3. Pregnancy or breast feeding.

Primary outcome measure(s)

  • Fluorescent signal of malignant lesion versus non-tumorous tissue. — Assessed directly during the bronchoscopy procedure
    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)).

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Groningen Groningen Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06809946 on ClinicalTrials.gov ↗ ← All trials in the Netherlands