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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
Sponsor:
Information provided by (Responsible Party):
Massimo Falconi, IRCCS San Raffaele

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
150 patients with a suspect of a sporadic NF-PanNEN will be considered for the study at the time of the first visit. All consecutive patients who will meet inclusion criteria, after informed consent, will be included. The enrollment will be completed only after the cytological/histological confirmation NF-PanNEN.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Fabio Giannone, MD, PhD +333401036108 giannone.fabio@hsr.it
Contact: Francesca Muffatti, MD 0226437697 muffatti.francesca@hsr.it

Locations
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Italy
IRCCS San Raffaele Hospital Recruiting
Milan, Italy, 20132
Contact: Massimo Falconi, Professor    0039 0226436046    massimo.falconi@hsr.it   
Contact: Stefano Partelli, MD PhD    0039 02 26437697    partelli.stefano@hsr.it   
Sub-Investigator: Fabio Giannone, MD         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Study Director: Stefano Partelli, MD, PhD IRCCS San Raffaele

Publications of Results:
Other Publications:

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Responsible Party: Massimo Falconi, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03918759     History of Changes
Other Study ID Numbers: DETECTYON study
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massimo Falconi, IRCCS San Raffaele:
Lymph node metastases
Diagnostic accuracy

Additional relevant MeSH terms:
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Neoplasm Metastasis
Endocrine Gland Neoplasms
Adenoma, Islet Cell
Pancreatic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases