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Post-Authorization Long-Term Safety Study of LUTATHERA
Sponsor: Advanced Accelerator Applications
Summary
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Official title: International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1014
Start Date
2018-11-28
Completion Date
2027-09-30
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
LUTATHERA
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie \[mCi\]) every 8 weeks for a total of 4 doses.
Locations (20)
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