Asymptomatic Small Pancreatic Endocrine Neoplasms.
Launched by IRCCS SAN RAFFAELE · Mar 14, 2017
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how to best manage small, non-functioning pancreatic tumors that are less than 2 cm in size. These tumors, known as non-functioning pancreatic endocrine neoplasms (NF-PNEN), are often found by chance and do not cause symptoms. The study will help doctors decide whether patients should have surgery to remove the tumor or if they can simply be monitored over time, a process called active surveillance. The trial is currently recruiting participants, who can be anyone over the age of 18.
To join the trial, patients must have a confirmed diagnosis of NF-PNEN that is 2 cm or smaller, either through a fine-needle aspiration test or certain imaging scans. Those who are already scheduled for surgery for their small tumors within the past year can also participate. However, individuals with larger tumors, certain genetic syndromes, or any symptoms related to these tumors will not be eligible. Participants will work closely with their doctors, who will guide them through the best management plan based on their individual situation.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age \> 18 years
- • Individuals with asymptomatic sporadic NF-PNEN ≤ 2 cm
- • Diagnosis has to be proven by a positive fine-needle aspiration (FNA) or by the presence of a measurable nodule on high-quality imaging technique (CT or MR) that is positive at 68Gallium DOTATOC-PET scan or Octreoscan.
- • Patients who undergo surgery for NF-PNEN\<2cm within 12 months. In these cases, diagnosis has to be proven by histological confirmation of NF-PNEN
- • Informed consent
- Exclusion Criteria:
- • NF-PNEN \> 2 cm of maximum diameter
- • Presence of genetic syndrome (MEN1, VHL, NF)
- • Presence of symptoms (specific symptoms suspicious of a clinical syndrome related to hypersecretion of bioactive compounds) or unspecific symptoms
About Irccs San Raffaele
IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, , Italy
Patients applied
Trial Officials
Massimo Falconi, Professor
Principal Investigator
IRCCS San Raffaele
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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