Diagnostic Accuracy of Preoperative Diagnostic Procedure in the Assessment of Lymph Node Metastases by NF-PanNENs
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|ClinicalTrials.gov Identifier: NCT03918759|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
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.
|Condition or disease|
|Non Functioning Pancreatic Endocrine Tumor|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||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|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2021|
- Accuracy of preoperative staging in detecting nodal metastases by evaluating and comparing sensitivity and specificity of the diagnostic techniques [ Time Frame: 2 years ]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
- Evaluate the prognostic role of the nodal involvement [ Time Frame: 5 years ]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.
- Evaluate the correlation between preoperative radiological and/or clinical data and nodal involvement [ Time Frame: 5 years ]This secondary outcome include the evaluation of other possible variables that can be associated with the risk of nodal metastases such as preoperative dimension in mm of the PanNEN, location, features at the imaging, standard uptake value (SUV).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918759
|Contact: Fabio Giannone, MD, PhDfirstname.lastname@example.org|
|Contact: Francesca Muffatti, MDemail@example.com|
|IRCCS San Raffaele Hospital||Recruiting|
|Milan, Italy, 20132|
|Contact: Massimo Falconi, Professor 0039 0226436046 firstname.lastname@example.org|
|Contact: Stefano Partelli, MD PhD 0039 02 26437697 email@example.com|
|Sub-Investigator: Fabio Giannone, MD|
|Study Director:||Stefano Partelli, MD, PhD||IRCCS San Raffaele|