Clinical trial · Observational
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
NCT03691064CI-TRIAL-00099534SALUSactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LUTATHERA | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- LUTATHERA
- description
- Treated per labeled LUTATHERA dosing regimen.
- interventionNames
- Drug: LUTATHERA
Primary outcomes (1)
- measure
- secondary cancers: incidence of secondary cancers
- timeFrame
- up to 7 years follow-up
- description
- incidence of secondary cancers
Secondary outcomes (5)
- measure
- safety profile: incidence of adverse events
- timeFrame
- up to 7 years follow-up
- description
- incidence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.