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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03691064

Acronym

SALUS

Enrollment

1014

Registered

2018-10-01

Start date

2018-11-28

Completion date

2027-09-30

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

Gastroenteropancreatic neuroendocrine tumours

Brief summary

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

Detailed description

To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

Interventions

DRUGLUTATHERA

Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie \[mCi\]) every 8 weeks for a total of 4 doses.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
secondary cancers: incidence of secondary cancers	up to 7 years follow-up	incidence of secondary cancers

Secondary

Measure	Time frame	Description
safety profile: incidence of adverse events	up to 7 years follow-up	incidence of adverse events
mortality	up to 7 years follow-up	mortality (all cause)
LUTATHERA dose per administration	completion of treatment phase (approximately 2 years total)	average dose per administration
LUTATHERA total dose	completion of treatment phase (approximately 2 years total)	average total dose administered
LUTATHERA number of administrations	completion of treatment phase (approximately 2 years total)	average number of LUTATHERA doses

Countries

France, Portugal, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026