Feasibility of Fluorescence Imaging with Bevacizumab-800CW During Bronchoscopy

University Medical Center Groningen (UMCG)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Lymph Node Involvement; Lung Neoplasms; Pulmonary Neoplasms

Treatments: Drug: injection with 25 mg bevacizumab-800CW before bronchoscopy; Drug: injection with 15 mg bevacizumab-800CW before bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06809946

202100285

2024-510793-24-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

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

Active Comparator group

Treatment:

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

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

Active Comparator group

Treatment:

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