Feasibility of Fluorescence Imaging with Bevacizumab-800CW During Bronchoscopy

NCT ID: NCT06809946

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-01

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.

Conditions

Lung Neoplasms; Pulmonary Neoplasms; Lymph Node Involvement

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

injection with 15 mg bevacizumab-800CW before bronchoscopy

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

injection with 25 mg bevacizumab-800CW before bronchoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Frederike Bensch, MD, PhD

Role: CONTACT

f.bensch@umcg.nl

0031503610280

Other Identifiers

2024-510793-24-00

Identifier Type: CTIS

Identifier Source: secondary_id

202100285

Identifier Type: -

Identifier Source: org_study_id