Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy (DEFLECT I)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Neoplasms; Pulmonary Nodule; Pulmonary Neoplasms; Lymph Node Involvement
• Intervention / Treatment: Drug: injection with 15 mg bevacizumab-800CW before bronchoscopy; Drug: injection with 25 mg bevacizumab-800CW before bronchoscopy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Frederike Bensch, MD, PhD; Phone Number: 0031503610280; Email: f.bensch@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
    • Contact: Frederike Bensch, MD, PhD; Email: f.bensch@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg	Drug: 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.
Experimental: Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLuorescence signal analyses	Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology results.	Up to 1 year
Optimal dose of bevacizumab-800CW	Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios.	Up to 1 year
Safety of bevacizumab-800CW injection and fluorescence molecular imaging	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.	Up to 24 hours after the fluorescence molecular bronchoscopy

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): August 17, 2028
• Study Completion (Estimated): August 17, 2028

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary nodule; Near-infrared fluorescence imaging; Molecular imaging; Bevacizumab-800CW; Fluorescence molecular bronchoscopy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: 202100285; 2024-510793-24-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No