68-Ga-labeled Octreotide Analogues PET in Duodenal-pancreatic Neuroendocrine Tumours

PHASE2CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

July 5, 2016

Conditions
Neuroendocrine Tumours
Interventions
DRUG

Diagnostic work up

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.

Trial Locations (21)

41121

Rita Conigliaro, Modena

42100

Laura Scaltriti, Guastalla

ASMN IRCCS Reggio Emilia, Reggio Emilia

43121

Pellegrino Crafa, Parma

Unknown

Irene Virgolini, Innsbruck

Nadia Cremonini, Bologna

Fernando Cirillo, Cremona

Diego Ferone, Genova

Giovanna Pepe, Milan

Luppi Gabriele, Modena

Piero Ferolla, Perugia

Antonio Chella, Pisa

Enrico Papini, Albano Laziale

Roberto Baldelli, Roma

Vittoria Rufini, Roma

Claudio De Angelis, Torino

Marco Gallo, Torino

Paolo Limone, Torino

Franco Grimaldi, Udine

Massimo Falconi, Verona

Roberto Castello, Verona

All Listed Sponsors
lead

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

NCT01673906 - 68-Ga-labeled Octreotide Analogues PET in Duodenal-pancreatic Neuroendocrine Tumours | Biotech Hunter | Biotech Hunter