drugset / Trial / NCT06240741

A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan

NCT06240741

NaSingle-groupOpen-labelDiagnostic

Summary

The purpose of this study was to evaluate the diagnostic performance of \[68Ga\]Ga-DOTA-TATE Positron Emission Tomography (PET)/Computerized Tomography (CT) imaging compared with conventional imaging (CIM) as standard of truth in patients with neuroendocrine neoplasms (NENs) and healthy volunteers (HVs). The data from this study was collected in order to provide the evidence for diagnosis of \[68Ga\]Ga-DOTA-TATE PET/CT imaging in patient with NENs in Japan.

Timeline

Start
2024-03-21
Primary completion
2024-12-27
Completion
2024-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject [68Ga]Ga-DOTA-TATE Diagnostic / imaging agent 2 mbq/kg Intravenous