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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510793-24-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg | Experimental |
| |
| Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection with 15 mg bevacizumab-800CW before bronchoscopy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)). | Assessed directly during the bronchoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| FLuorescence signal analyses | Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology results. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederike Bensch, MD, PhD | Contact | 0031503610280 | f.bensch@umcg.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Netherlands |
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|
| injection with 25 mg bevacizumab-800CW before bronchoscopy | 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. |
|
| 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. | Up to 24 hours after the fluorescence molecular bronchoscopy |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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