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

PHASE3CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

December 27, 2024

Study Completion Date

December 27, 2024

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

Trial Locations (8)

277 8577

Novartis Investigative Site, Kashiwa

812-8582

Novartis Investigative Site, Fukuoka

060 8648

Novartis Investigative Site, Sapporo

920 8641

Novartis Investigative Site, Kanazawa

236-0004

Novartis Investigative Site, Yokohama

104 0045

Novartis Investigative Site, Chuo Ku

813-0017

Novartis Investigative Site, Fukuoka

606 8507

Novartis Investigative Site, Kyoto

Sponsors
All Listed Sponsors
collaborator

Eckert & Ziegler Radiopharma GmbH

UNKNOWN

lead

Novartis Pharmaceuticals

INDUSTRY