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NCT Number: NCT03691064

Post-Authorization Long-Term Safety Study of LUTATHERA

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative site, Clichy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lutathera

Drug

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

Other names: Lu 177 dotatate

Primary outcomes

  1. secondary cancers: incidence of secondary cancers

    Time frame: up to 7 years follow-up

    incidence of secondary cancers

Secondary outcomes

  1. safety profile: incidence of adverse events

    Time frame: up to 7 years follow-up

    incidence of adverse events

  2. mortality

    Time frame: up to 7 years follow-up

    mortality (all cause)

  3. LUTATHERA dose per administration

    Time frame: completion of treatment phase (approximately 2 years total)

    average dose per administration

  4. LUTATHERA total dose

    Time frame: completion of treatment phase (approximately 2 years total)

    average total dose administered

  5. LUTATHERA number of administrations

    Time frame: completion of treatment phase (approximately 2 years total)

    average number of LUTATHERA doses

Sponsors and collaborators

Lead sponsor

Advanced Accelerator Applications

Industry

Registry information

Official study 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

Acronym: SALUS

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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