drugset / Trial / NCT06240741
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [68Ga]Ga-DOTA-TATE | Diagnostic / imaging agent | 2 mbq/kg | Intravenous |