Feasibility of Fluorescence Imaging with Bevacizumab-800CW During Bronchoscopy

Phase 1

Not yet recruiting

• Conditions: Lung Neoplasms; Pulmonary Neoplasms; Lymph Node Involvement
• Interventions: Drug: injection with 15 mg bevacizumab-800CW before bronchoscopy; Drug: injection with 25 mg bevacizumab-800CW before bronchoscopy

• Registration Number: NCT06809946
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Fluorescence molecular imaging arm with bevacizumab-800CW at dose of 15 mg	injection with 15 mg bevacizumab-800CW before bronchoscopy	-
Fluorescence molecular imaging arm with bevacizumab-800CW at dose of 25 mg	injection with 25 mg bevacizumab-800CW before bronchoscopy	-

Primary Outcome Measures

Name	Time	Method
In vivo fluorescent signal of malignant lesion versus non-tumorous tissue	Assessed directly during the bronchoscopy procedure