Use of DOTATOC labeled with V-Cu64 in PET-CT imaging of neuroendocrine tumors

Condition studied

Neoplasms

Investigational medicinal product(s)

Eligibility

Primary endpoint

Demonstration of the bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on number of visualized lesions between interventions. Number of visualized lesions (visualization of at least the same lesions between interventions) for 95% of the study population, Demonstration of bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on: SUV_MAX measurement of lesions imaged in both interventions. Accuracy in SUV_MAX measurement of lesions imaged in both interventions, SUV_MAX in the copper study not less than 90% of SUV_MAX in the 68Ga study for each lesion for 95% of the population, averaged result for descriptions by two independent physicians.

Endpoint detail

Safety monitoring. Collection of data on adverse events