Clinical trial · Observational
Diagnostic Accuracy of Preoperative Diagnostic Procedure in the Assessment of Lymph Node Metastases by NF-PanNENs
Diagnostic Accuracy of 68Gallium Positron Emission Tomography/ Magnetic Resonance Imaging (68Ga PET/MRI), Endoscopic Ultrasound (EUS) and Computed Tomography in the Assessment of Lymph Node Metastases by Nonfunctioning Pancreatic Neuroendocrine Neoplasms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pancreatic Neuroendocrine Neoplasms (PanNEN) are a heterogeneous group of neoplasms that arise from the endocrine cells of the pancreatic gland. Non-functioning (NF-PanNEN) represents the most common forms and do not produce syndromes due to hormonal hypersecretion. Several prognostic factors have been demonstrated for NF-PanNEN. The presence of nodal metastasis and lymph node ratio are widely considered predictors of disease-free survival and even the number of positive nodes has been found to be associated with recurrence. In addition to traditional imaging exams, diagnostic work-up should include a Positron Emission Tomography/CT with 68Ga labeled somatostatin analogues, which have shown a high sensitivity and specificity while 18F-FDG PET can be associated for evaluating the possible presence of a high-grade component. Moreover, pancreatic endoscopic ultrasound (EUS) is usually part of the preoperative staging both for imaging details and cytological sampling. Therefore an accurate identification of nodal metastases preoperatively may have important implications for the extent of surgical resection and lymphadenectomy and even for a prognostic outcome. In this study the investigators will evaluate prospectively the accuracy of these diagnostic exams in detecting the lymph node status. Patients with sporadic NF-PanNEN who are candidates for surgical resection will undergo CE-CT scan, 68Ga DOTATOC (and eventually 18F-FDG) PET/MRI and EUS with FNA/B. Reference standard for defining the presence of nodal metastases is represented by pathological examination on the specimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Functioning Pancreatic Endocrine Tumor | Non-Functioning Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Accuracy of preoperative staging in detecting nodal metastases by evaluating and comparing sensitivity and specificity of the diagnostic techniques
- timeFrame
- 2 years
- description
- The primary endpoint of the study is to assess the accuracy of preoperative diagnostic procedures in terms of sensitivity and specificity in detecting nodal metastases in sporadic NF-PanNEN
Secondary outcomes (2)
- measure
- Evaluate the prognostic role of the nodal involvement
- timeFrame
- 5 years
- description
- The secondary outcomes include the assessment of the prognostic role of nodal involvement on disease/progression free survival in patients who undergo a pancreatic resection for a Non-functioning Pancreatic Neoplasms.
- measure
- Evaluate the correlation between preoperative radiological and/or clinical data and nodal involvement
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Individuals with a diagnosis of NF-PanNEN undergoing standard pancreatic resection (pancreatoduodenectomy, left pancreatectomy, total pancreatectomy) * Cytologically/histologically proven diagnosis of NF-PanNEN. * Informed consent Exclusion Criteria: * Age \< 18 years * Absence of cytological/histological confirmation * Presence of functioning PanNEN * Presence of genetic syndrome (MEN1, VHL, NF) * Patients undergone previously to an EUS in another institution with a FNA/B positive for NET
References
Publications (10)
- BACKGROUNDBoninsegna L, Panzuto F, Partelli S, Capelli P, Delle Fave G, Bettini R, Pederzoli P, Scarpa A, Falconi M. Malignant pancreatic neuroendocrine tumour: lymph node ratio and Ki67 are predictors of recurrence after curative resections. Eur J Cancer. 2012 Jul;48(11):1608-15. doi: 10.1016/j.ejca.2011.10.030. Epub 2011 Nov 28. PMID 22129889
- BACKGROUNDHashim YM, Trinkaus KM, Linehan DC, Strasberg SS, Fields RC, Cao D, Hawkins WG. Regional lymphadenectomy is indicated in the surgical treatment of pancreatic neuroendocrine tumors (PNETs). Ann Surg. 2014 Feb;259(2):197-203. doi: 10.1097/SLA.0000000000000348. PMID 24253141
- BACKGROUNDPartelli S, Javed AA, Andreasi V, He J, Muffatti F, Weiss MJ, Sessa F, La Rosa S, Doglioni C, Zamboni G, Wolfgang CL, Falconi M. The number of positive nodes accurately predicts recurrence after pancreaticoduodenectomy for nonfunctioning neuroendocrine neoplasms. Eur J Surg Oncol. 2018 Jun;44(6):778-783. doi: 10.1016/j.ejso.2018.03.005. Epub 2018 Mar 17. PMID 29610023
- BACKGROUNDDeppen SA, Blume J, Bobbey AJ, Shah C, Graham MM, Lee P, Delbeke D, Walker RC. 68Ga-DOTATATE Compared with 111In-DTPA-Octreotide and Conventional Imaging for Pulmonary and Gastroenteropancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis. J Nucl Med. 2016 Jun;57(6):872-8. doi: 10.2967/jnumed.115.165803. Epub 2016 Jan 14. PMID 26769864
- BACKGROUNDMiyazaki M, Ohtsuka M, Miyakawa S, Nagino M, Yamamoto M, Kokudo N, Sano K, Endo I, Unno M, Chijiiwa K, Horiguchi A, Kinoshita H, Oka M, Kubota K, Sugiyama M, Uemoto S, Shimada M, Suzuki Y, Inui K, Tazuma S, Furuse J, Yanagisawa A, Nakanuma Y, Kijima H, Takada T. Classification of biliary tract cancers established by the Japanese Society of Hepato-Biliary-Pancreatic Surgery: 3(rd) English edition. J Hepatobiliary Pancreat Sci. 2015 Mar;22(3):181-96. doi: 10.1002/jhbp.211. Epub 2015 Feb 17. PMID 25691463
- BACKGROUNDToste PA, Kadera BE, Tatishchev SF, Dawson DW, Clerkin BM, Muthusamy R, Watson R, Tomlinson JS, Hines OJ, Reber HA, Donahue TR. Nonfunctional pancreatic neuroendocrine tumors <2 cm on preoperative imaging are associated with a low incidence of nodal metastasis and an excellent overall survival. J Gastrointest Surg. 2013 Dec;17(12):2105-13. doi: 10.1007/s11605-013-2360-9. Epub 2013 Oct 8.