Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy

Phase 2Not Yet RecruitingNCT06809946

University Medical Center Groningen20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Neoplasms Pulmonary Neoplasms Lymph Node Involvement Pulmonary Nodule

Interventions

injection with 15 mg bevacizumab-800CW before bronchoscopyDRUG

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 bronchoscopyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

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)).

Time frame: Assessed directly during the bronchoscopy procedure

Secondary Outcomes

FLuorescence signal analyses

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

Time frame: 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.

Time frame: 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.

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

Central Contacts

Frederike Bensch, MD, PhD

CONTACT

0031503610280 f.bensch@umcg.nl

Data from ClinicalTrials.gov

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