Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: injection with 15 mg bevacizumab-800CW before bronchoscopy, injection with 25 mg bevacizumab-800CW before bronchoscopy.
- Who it may be relevant to
- Registry conditions: Lung Neoplasms, Pulmonary Neoplasms, Lymph Node Involvement, Pulmonary Nodule. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy in Patients With a Pulmonary Lesion Considered to be Malignant - DEFLECT I
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.
Interventions
- 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. - 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.
Primary outcome measures
- Fluorescent signal of malignant lesion versus non-tumorous tissue. [Time frame: Assessed directly during the bronchoscopy procedure]
Secondary outcome measures (3)
- FLuorescence signal analyses [Time frame: Up to 1 year]
- Optimal dose of bevacizumab-800CW [Time frame: Up to 1 year]
- Safety of bevacizumab-800CW injection and fluorescence molecular imaging [Time frame: Up to 24 hours after the fluorescence molecular bronchoscopy]
Eligibility criteria
Inclusion criteria
- Signed informed consent prior to participation in the study.
- Age ≥ 18 years.
- 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).
- 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
- History of infusion reactions to bevacizumab.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Pregnancy or breast feeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT06809946 · 202100285 · 2024-510793-24-00