NCT03691064Active, not recruiting
Post-Authorization Long-Term Safety Study of LUTATHERA
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
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1014 (actual)
- First submitted
- 22 Sept 2018
- Start date
- 28 Nov 2018
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Advanced Accelerator Applications
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT03691064
What you commit to
- Study type: Observational
- Participants enrolled: 1014
- From 28 Nov 2018 to the primary completion date, 30 Sept 2027
- 17 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hypersensitivity to Lutathera (active substance or any of the excipients),
Lab values
- presence of kidney failure with creatinine clearance \< 30 mL/min.
Other
- presence of established or suspected pregnancy or pregnancy not excluded,
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| - Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| - Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| - Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| The Ohio State University Wexner Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health & Sciences University Hospital Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Mason in Seattle Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.