suspected malignant pulmonary disease (lung lesions and/or lymph nodes suspicious for lung cancer)
Conditions
Brief summary
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)).
Detailed description
Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology result., Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios., Assessment of safety of bevacizumab-800CW injection and procedures in relation with fluorescent 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.
Interventions
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology result., Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios., Assessment of safety of bevacizumab-800CW injection and procedures in relation with fluorescent 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. | — |
Outcome results
None listed