A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea

A Post Marketing Surveillance on Lutathera® (Lutetium (177Lu) Oxodotreotide, 177Lu-DOTA0-Tyr3-Octreotate) in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) in Korea

ClinicalTrials.gov Identifier: NCT04946305

Novartis Reference Number: CAAA601A12403

Last Update: Jun 07, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.

Condition

Somatostatin Receptor-positive GEP-NET

Phase

Not Given

Overall status

Recruiting

Start date

May 11, 2022

Completion date

Jun 30, 2023

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Other

Lutathera

Prospective observational study. There is no treatment allocation. Patients administered Lutathera by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.

- somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

Patients who are willing to provide written informed consent.

Exclusion Criteria:

1. Patients with contraindication according to prescribing information for Lutathera in Korea.