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Brief Title: 68-Ga-labeled Octreotide Analogues PET in Duodenal-pancreatic Neuroendocrine Tumours
Official Title: Accuracy and Clinical Impact of 68-Ga-labeled Octreotide Analogues PET in Diagnosis and Staging of Duodenal-pancreatic Neuroendocrine Tumours; Proposal of a Multicenter, Prospective Clinical Trial
Study ID: NCT01673906
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Irene Virgolini, Innsbruck, , Austria
Laura Scaltriti, Guastalla, Reggio Emilia, Italy
ASMN IRCCS Reggio Emilia, Reggio Emilia, RE, Italy
Enrico Papini, Albano Laziale, Roma, Italy
Nadia Cremonini, Bologna, , Italy
Fernando Cirillo, Cremona, , Italy
Diego Ferone, Genova, , Italy
Giovanna Pepe, Milano, , Italy
Rita Conigliaro, Modena, , Italy
Luppi Gabriele, Modena, , Italy
Pellegrino Crafa, Parma, , Italy
Piero Ferolla, Perugia, , Italy
Antonio Chella, Pisa, , Italy
Roberto Baldelli, Roma, , Italy
Vittoria Rufini, Roma, , Italy
Claudio De Angelis, Torino, , Italy
Marco Gallo, Torino, , Italy
Paolo Limone, Torino, , Italy
Franco Grimaldi, Udine, , Italy
Massimo Falconi, Verona, , Italy
Roberto Castello, Verona, , Italy
Name: Lorenzo Camellini, MD
Affiliation: Gastroenterology and Digestive Endoscopy Unit, Santa Maria Hospital, Reggio Emilia, Italy.
Role: STUDY_DIRECTOR
Name: Gabriele Carlinfante, MD
Affiliation: Unit of Pathology, Santa Maria Nuova Hospital, Reggio Emilia, Italy
Role: STUDY_DIRECTOR
Name: Andrea Frasoldati, MD
Affiliation: Department of Endocrinology, Thyroid Disease Center-Arcispedale Santa Maria Nuova of Reggio Emilia, Reggio Emilia, Italy.
Role: STUDY_DIRECTOR
Name: Armando Froio, Biologist
Affiliation: Nuclear Medicine Unit, Santa Maria Nuova Hospital
Role: STUDY_DIRECTOR
Name: Tiziana Cassetti, Biologist
Affiliation: Gastroenterology and Digestive Endoscopy Unit, Santa Maria Hospital, Reggio Emilia, Italy.
Role: STUDY_DIRECTOR