Lung Neoplasms, Lymph Node Involvement, Pulmonary Neoplasms, Pulmonary Nodule
Conditions
Keywords
Fluorescence molecular bronchoscopy, Bevacizumab-800CW, Near-infrared fluorescence imaging, Molecular imaging, Pulmonary nodule
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.
Interventions
DRUGinjection 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.
DRUGinjection 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.
Sponsors
University Medical Center Groningen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescent signal of malignant lesion versus non-tumorous tissue. | Assessed directly during the bronchoscopy procedure | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FLuorescence signal analyses | Up to 1 year | Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology results. |
| Optimal dose of bevacizumab-800CW | Up to 1 year | Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios. |
| Safety of bevacizumab-800CW injection and fluorescence molecular imaging | Up to 24 hours after the fluorescence molecular bronchoscopy | 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. |
Countries
Netherlands
Contacts
CONTACTFrederike Bensch, MD, PhD
Outcome results
None listed