breast, gastrointestinal, genitourinary, head and neck, hepatobiliary, Histologically confirmed solid malignancy (e.g., sarcoma)
Conditions
Brief summary
Tumor-to-background ratio (TBR) ≥ 1.5 on ex vivo imaging of resected specimens., Proportion of patients with histologically confirmed clear surgical margins (≥1 mm) in fluorescent vs. non-fluorescent areas
Detailed description
Concordance between fluorescence signal and histopathology at wound bed and specimen, Number of additional fluorescent lesions biopsied and confirmed as tumor, as well as the number of false-positive and false-negative lesions, Mean fluorescence intensity (MFI) in metastatic vs. non-metastatic lymph nodes, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Interventions
DRUGVERDYE 5 mg/ml poeder voor oplossing voor injectie
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor-to-background ratio (TBR) ≥ 1.5 on ex vivo imaging of resected specimens., Proportion of patients with histologically confirmed clear surgical margins (≥1 mm) in fluorescent vs. non-fluorescent areas | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance between fluorescence signal and histopathology at wound bed and specimen, Number of additional fluorescent lesions biopsied and confirmed as tumor, as well as the number of false-positive and false-negative lesions, Mean fluorescence intensity (MFI) in metastatic vs. non-metastatic lymph nodes, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | — |
Countries
Netherlands
Outcome results
None listed