NCT06240741

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

A Prospective, Open-label, Multi-center, Single Arm, Phase III Study of [68Ga]Ga-DOTA-TATE in the Diagnosis of Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed description

A total of 71 participants (48 patients with confirmed/suspected NENs and 23 HVs) were enrolled to ensure that at least 70 participants (47 patients with confirmed/suspected NENs and 23 HVs) were evaluable for the co-primary endpoints. All enrolled participants were administered \[68Ga\]Ga-DOTA-TATE and PET/CT scan. The co-primary endpoints of the subject-level sensitivity and the subject-level specificity were assessed by comparing the central reading results of the \[68Ga\]Ga-DOTA-TATE PET/CT scan to the central reading results of Conventional imaging (CIM).

Conditions

• Neuroendocrine Neoplasms

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-DOTA-TATE	Single intravenous injection of \[68Ga\]Ga-DOTA-TATE determined by body weight (2 Mega-Becquerel (MBq) / kilogram (kg) (0.054 Millicurie (mCi)/kilogram (kg)) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)) at the imaging day (Day 1).
DRUG	68Ge/68Ga Generator	Radionuclide generator

Timeline

• Start date: 2024-03-21
• Primary completion: 2024-12-27
• Completion: 2024-12-27
• First posted: 2024-02-05
• Last updated: 2026-02-03
• Results posted: 2026-02-03

Locations

8 sites across 1 country: Japan