A long-term follow up safety study of Lutathera (SALUS study)

• Research type

  Research Study

• Full title

  An 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 (SALUS study).

• IRAS ID

  251180

• Contact name

  Shaunak Navalkissor

• Contact email

  s.navalkissoor@nhs.net

• Sponsor organisation

  Advanced Accelerator Applications

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  6 years, 4 months, 31 days

• Research summary

  This is an international, non-interventional, post-authorisation long-term safety study of a drug called Lutathera. The study will involve approximately 1000 patients in five countries (UK, France, Portugal, Finland, US). \n\nThe study will involve collecting and analysing patients’ data from hospital medical records. The purpose is to assess the long-term safety of Lutathera. At the time of recruitment to the study, patients will also be asked to complete a short questionnaire about potential radiation exposure.\n\nThe population for this study is adult patients diagnosed with Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) who received treatment with Lutathera.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  18/SW/0190

• Date of REC Opinion

  6 Aug 2018

• REC opinion

  Favourable Opinion