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Spots Global Cancer Trial Database for 68-Ga-labeled Octreotide Analogues PET in Duodenal-pancreatic Neuroendocrine Tumours

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Trial Identification

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

Interventions

Diagnostic work up

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

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