Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours

NCT ID: NCT06121622

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2029-12-31

Brief Summary

The goal of this prospective observational study is to generate new personalised 3D preclinical models of pancreatic neuroendocrine tumors. The models will be exploited for studying the mechanisms underlying disease development and progression, as well as for performing drug testing. For the development of the newly proposed models, patients' surgical specimens will be evaluated by the Pathological Unit. If the presence of pathological material in excess, not required for the routine diagnostic procedure, is confirmed, such material will be employed for the generation of the proposed personalised models.

Detailed Description

Pancreatic neuroendocrine tumors (PanNETs) are characterized by highly heterogeneous biological behavior. Another distinctive feature of these neoplasms is the presence of a dense vascular network, reminiscent of their physiological counterpart. Indeed, the tumor microenvironment plays a critical role in these neoplasms and influence their therapeutic management. Although they are typically indolent in nature, approximately 40% of PanNET patients are metastatic at diagnosis, requiring non-surgical treatments such as somatostatin therapy, chemotherapy, targeted therapy, and peptide receptor radionuclide therapy (PRRT). Furthermore, 1 out of 5 patients experience disease recurrence after surgical resection, necessitating pharmacological therapies. Currently, no specific recommendations exist on the most effective therapeutic sequence to follow in presence of metastatic disease/disease relapse. One of the main reasons behind this unmet clinical need is the scarcity of available preclinical models of these neoplasms able to accurately reproduce the biology and physiology of the primary tumor and that can be used as valid platforms for drug testing.

The study aims to generate a new 3D in vitro model of PanNET, replicating the complex primary tumor in vitro, including also the tumor microenvironment (e.g., vascular network and stroma, essential elements of these neoplasms), personalised for each patient. Indeed, for the development of the newly proposed models, patients' surgical specimens will be initially evaluated by the Pathological Unit and, in the presence of pathological material in excess not required for the routine diagnostic procedure, it will be employed for the generation of the proposed personalised models. 3D culture techniques (e.g., 3D bioprinting) will be used for the development of the models. Moreover, in order to further mimic in vitro the in vivo environment, the models will be maintained under dynamic conditions.

These newly proposed models will be exploited for studying the mechanisms underlying disease development and progression, as well as for performing drug testing.

Conditions

Pancreatic Neuroendocrine Tumor

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• patients who undergo pancreatic surgical resection for non-functioning pancreatic neuroendocrine tumor
• age ≥ 18 years
• informed consent

Exclusion Criteria

• non-pancreatic neuroendocrine tumor histological diagnosis
• age < 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Anna Battistella

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS San Raffele Institute

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Massimo Falconi, Professor

Role: CONTACT

falconi.massimo@hsr.it

0039 022643 6046

Anna Battistella, MD

Role: CONTACT

battistella.anna1@hsr.it

0039 02 26433484

Facility Contacts

Stefano Partelli, MD, PhD

Role: primary

partelli.stefano@hsr.it

0039 02 2643 7697

Cristina Scielzo, PhD

Role: backup

scielzo.cristina@hsr.it

0039 02 26436487

Other Identifiers

3DPanNET

Identifier Type: -

Identifier Source: org_study_id