68-Ga-labeled Octreotide Analogues PET in Duodenal-pancreatic Neuroendocrine Tumours
Condition: Neuroendocrine Tumours
MeSH terms: Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 2

Summary: 
      The diagnostic work-up of patients suspected of having neuroendocrine tumours (NETs) has
      traditionally been a challenging issue. The last two decades have been marked by the
      application to use in the diagnosis of NETs of 3 newly available diagnostic techniques:
      endoscopic ultrasonography (EUS), multidetector CT (MDCT), and more recently, positron
      emission tomography using 68Ga-labelled octreotide analogues (PET). In a prospective study
      conducted at a single referral centre that compared PET with conventional somatostatin
      receptor scintigraphy and MDCT in diagnosis, staging and follow-up of patients affected by
      NET, PET detected more primary and secondary lesions than other methods. Recent studies
      investigated the clinical impact of PET in the management of patients affected by NET,
      previously studied by MDCT. The investigators recently reported the results of the
      investigation of 19 patients suspected of having primary pancreatic NET and studied by PET,
      MDCT and EUS. The investigators preliminary data suggest that PET may be slightly more
      sensitive than MDCT in detecting small (<2cm) pancreatic lesions; accuracy of PET and EUS is
      probably similar. No prospective study has yet been devoted to evaluate the accuracy of PET
      in the diagnosis and staging of primary duodenal-pancreatic NETs. Furthermore, the clinical
      impact of the adjunct of PET to the traditional protocols of diagnosis and staging of these
      tumours waits to be thoroughly evaluated. Thus the appropriate place of PET in the diagnostic
      algorithm of patients suspected of having duodenal-pancreatic NET remains undefined.

      The main aim of this project is to prospectively compare the accuracy of PET and MDCT in the
      diagnosis and staging of patients suspected of having duodenal-pancreatic NETs. The
      investigators hypothesised that PET is superior to MDCT in the diagnosis of these neoplasm
      (the dimension of the study sample is estimated in order to detect a 10% difference). The
      impact of PET on management plan of affected patients will also be evaluated. As a secondary
      endpoint of the study, the investigators will compare EUS, PET and MDCT in the diagnosis of
      primary duodenal-pancreatic NET. The study is designed as a multicentre, prospective,
      non-randomised clinical trial. All patients will undergo MDCT, PET and EUS in this fixed
      order.
    


Intervention name(s): Diagnostic work up
Intervention type(s): Drug
Intervention description(s): Patients will undergo MDCT, PET and EUS. Every attempt will be made to achieve a pre-operative cytologic diagnosis of any primary lesion by EUS-FNA. All diagnostic tests (MDCT, PET, EUS) should be performed during a two month time span, in this fixed order. The nuclear medicine doctor will be blinded of findings of MDCT. The gastroenterologist will be blinded about the findings of MDCT and PET until he has completed the diagnostic EUS. For ethical reasons, the findings of MDCT and PET will be disclosed to her/him, while the patient is still sedated in the operating room, just before the FNA. The minimal technical requirement for the techniques, the requested levels of clinical competence of the operators and the procedure for critical revision of radiological and cytological and histological specimens are detailed in the protocol. For PET any 68Ga -labeled-octreotide analogue will be allowed. Before EUS, an extended-esophagogastroduodenoscopy (until the Treitz) until will be performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: positron-emission tomography; neuroendocrine tumors; endosonography; tomography, X-ray computed; biopsy, fine needle; sensitivity and sensibility