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

NCT06240741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-02-03

Study results available
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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.

Conditions

  • Neuroendocrine Neoplasms

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06240741 on ClinicalTrials.gov