Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1. Degree of graphic gamma positivity (InGG immunography will be performed to determine the degree of concordance, sensitivity, specificity, positive predictive value, negative predictive value). Measurement time: at 4 and 18-24 hours after the administration of Radioimmunoconjugate.
2. Overexpression of the EGFR (overexpression of EGFR in the biopsy as High, Moderate, Low, Negative). Measurement time: At baseline.
Key secondary outcomes:
Adverse events (Incidence of Adverse Events (AE) reported by the patient and by laboratory tests measured as: Occurrence of any AE (Yes, No); Description of the AE (Name of the adverse event); Duration of the AE (Difference between the start and end date of the AE); Intensity of the AE (Light, Moderate, Severe, AE that threatens or incapacitates and AE that causes death); Severity of the AE (Serious, Not serious); Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or squeal], Causal relationship (1. Definitive 2. Very probable, 3. Probable, 4. Possible, 5. Unrelated 6. Unknown)). Measurement time: 28 days after administration