Clinical Trial · NCT06240741

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

Overview

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.

Sponsor

Novartis

Phase

Phase 3

Contacts

Novartis Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT06240741

Drug / Compound

DOTATATE

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Women of childbearing potential must havehad a negative urine or blood pregnancy test.Key
For HVs only: Male or female participant in good health condition as determined by no clinically significant findings from medical history, physical examination, vital signs, lab test and ECG
ECOG performance status 0-2
For patient with NENs only: Participants were to be confirmed NENs based on histopathology, imaging and other relevant examination, or with suspected NENs which localization could not have been confirmed by CIM

Exclusion

Inability to complete the needed investigational and conventional imaging due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
Known allergy, hypersensitivity, or intolerance to \[68Ga\]Ga-DOTA-TATE and \[111In\]In-Pentetreotide
Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of \[68Ga\]Ga-DOTA-TATE
Participants who were lactating.
Participants who were pregnant.
Short-acting analogs of somatostatin can be used up to 24 hours before injection of \[68Ga\]Ga-DOTA-TATE.
Use of other investigational drugs within 30 days before screening
Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation
Therapeutic use of any somatostatin analogue except for the following washout period
Long-acting analogs of somatostatin can be used up to 28 days before injection of \[68Ga\]Ga-DOTA-TATE.