Post-Authorization Long-Term Safety Study of LUTATHERA

Running, not enrolling

Conditions studied: Neuroendocrine Tumors

In brief

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Key facts

Study ID

NCT03691064

Run by

Advanced Accelerator Applications

People needed

1014

Starts

2018-11-28

Expected to finish

2027-09-30

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients (fulfilling the definition of "age of majority" per local regulations),
• with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
• and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).

You may not qualify if…

• Hypersensitivity to Lutathera (active substance or any of the excipients),
• presence of established or suspected pregnancy or pregnancy not excluded,
• presence of kidney failure with creatinine clearance < 30 mL/min.

Where it is running

• Banner MD Anderson Cancer Center — Phoenix, Arizona, United States
• The Ohio State University Wexner Medical Center — Portland, Ohio, United States
• Oregon Health & Sciences University Hospital — Portland, Oregon, United States
• Virginia Mason in Seattle — Seattle, Washington, United States
• Novartis Investigative site — Clichy, France
• Novartis Investigative site — Lyon, France
• Novartis Investigative site — Villejuif, France
• Novartis Investigative site — Coimbra, Coimbra District, Portugal
• Novartis Investigative site — Santiago de Compostela, La Corunya, Spain
• Novartis Investigative site — Majadahonda, Madrid, Spain
• Novartis Investigative site — Birmingham, United Kingdom
• Novartis Investigative site — Cambridge, United Kingdom
• Novartis Investigative site — Glasgow, United Kingdom
• Novartis Investigative site — Liverpool, United Kingdom
• Novartis Investigative site — London, United Kingdom
• Novartis Investigative site — London, United Kingdom
• Novartis Investigative site — London, United Kingdom
• Novartis Investigative site — London, United Kingdom
• Novartis Investigative site — Manchester, United Kingdom
• Novartis Investigative site — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.