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NCT Number: NCT06809946

Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy

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.

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Key information

Conditions

Lung Neoplasms Lung Diseases Lymph Node Involvement Neoplasms Neoplasms by Site Pulmonary Neoplasms Pulmonary Nodule Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Groningen

Groningen, Netherlands

Location contact

Frederike Bensch, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

injection with 15 mg bevacizumab-800CW before bronchoscopy

Drug

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

Drug

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.

Primary outcomes

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

    Time frame: 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)).

Secondary outcomes

  1. FLuorescence signal analyses

    Time frame: Up to 1 year

    Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology results.

  2. Optimal dose of bevacizumab-800CW

    Time frame: Up to 1 year

    Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios.

  3. Safety of bevacizumab-800CW injection and fluorescence molecular imaging

    Time frame: Up to 24 hours after the fluorescence molecular bronchoscopy

    Assessment of safety of bevacizumab-800CW injection and procedures in relation with fluorescence molecular imaging through summaries of adverse events, including data on the additional time (in minutes) needed for in vivo qualitative and quantitative assessment of the fluorescent signal. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Frederike Bensch, MD, PhD

CONTACT

[email protected]

0031503610280

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy in Patients With a Pulmonary Lesion Considered to be Malignant - DEFLECT I

Acronym: DEFLECT I

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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