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

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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.

Study Locations

Korea, Republic of
Novartis Investigative Site
Recruiting
Seongnam Si, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06351
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 110-799
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 138-736
-
Korea, Republic of

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

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