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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06121622
Other study ID # 3DPanNET
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 16, 2024
Est. completion date December 2029

Study information

Verified date March 2024
Source IRCCS San Raffaele
Contact Massimo Falconi, Professor
Phone 0039 022643 6046
Email falconi.massimo@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 2029
Est. primary completion date November 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS San Raffele Institute Milan MI

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours Generation of new 3D preclinical models of pancreatic neuroendocrine tumors for the study of the disease biology and for the assessment of drug response from the day of surgery until 3 years from surgery
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