A retrospective study of patients treated with Lutathera

  • Research type

    Research Study

  • Full title

    An international, non-interventional, post-authorization retrospective registry of patients treated with Lutathera® (lutetium (177Lu) oxodotreotide), to assess the efficacy and safety of Lutathera® for the treatment of pancreatic neuroendocrine tumors (pNETs).

  • IRAS ID

    248950

  • Contact name

    John Ramage

  • Contact email

    johnramage@nhs.net

  • Sponsor organisation

    Advanced Accelerator Applications

  • Clinicaltrials.gov Identifier

    NA, NA

  • Duration of Study in the UK

    0 years, 6 months, 0 days

  • Research summary

    This is an international, non-interventional, post-authorisation retrospective registry of patients diagnosed with pancreatic neuroendocrine tumors (pNETs) and treated with a drug called Lutathera.

    The study will involve collecting and analysing patients' data from hospital medical records. The purpose is to find out how safe and effective Lutathera is. At the time of recruitment to the study, patients will also be asked to complete a short questionnaire about potential radiation exposure.

    The population for this study is patients with pNETs who receive Lutathera. It is expected to recruit approximately 120 patients from 3 European countries: the UK, France and Spain.

  • REC name

    West of Scotland REC 4

  • REC reference

    18/WS/0116

  • Date of REC Opinion

    12 Jul 2018

  • REC opinion

    Further Information Favourable Opinion