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All Drugs and Chemicals

Somatostatin

Edotreotide

Edotreotide lutetium LU-177

Radiopharmaceuticals

177Lu labeled somatostatin receptors targeting ligand

177Lu-DOTATOC

Ebrahim Delpassand, MD

Rodolfo Nunez, MD

Afshin Shafie, MD

Ayman Gaber, MD

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET.

The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.

Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.

A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.

determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI

Excel Diagnostics and Nuclear Oncology Center

GEP- and Pulm- NET patients referred to the U.O.C. of Medical Oncology of the FPG - IRCCS since 01/01/2010 up to the date of approval of the study.

GEP- and Pulm- NET patients referred to the U.O.C. of Medical Oncology of the FPG - IRCCS starting from the date of approval of the study for the following 36 months.

Maria Grazia Maratta, MD

Giovanni Schinzari, MD

Maria Grazia Maratta

Giovanni Schinzari

Observational ambispective monocentric study on the clinical, laboratory, pathological and molecular characteristics of patients suffering from gastroenteropancreatic tract and pulmonary neuroendocrine tumors and their prognostic and predictive value.

Neuroendocrine tumors (NETs) are a heterogeneous group of rare epithelial neoplasms arising from cells of the diffuse neuroendocrine system. In recent years their incidence has been constantly increasing and up to 80% of cases already begin in an advanced stage. The most frequent site of primary localization is the gastroenteropancreatic tract (GEP-NET) in 60% of cases, followed, in 25%, by the lung (L-NET). Clinically, NETs are classified as functioning (F) or non-functioning (NF) based on the presence of symptoms caused by hormonal secretion produced by tumor cells. NETs are characterized by great clinical and biological, inter- and intra-tumoral heterogeneity. The WHO classification identifies four categories: well-differentiated NETs, G1, G2 and G3, and poorly differentiated neuroendocrine carcinomas (NECs), which represent 10%-20% of all neuroendocrine neoplasms. This classification, together with the TNM stage according to the American Joint Committee on Cancer (AJCC 8th edition) takes on an important prognostic value. However, these two criteria are not exhaustive in predicting the aggressiveness of the pathology nor the response to oncological therapies. There is therefore a clear clinical need, to date unsatisfied, for new prognostic and predictive biomarkers, which can better define the heterogeneity of NETs by implementing classification and staging, to guide prognosis and support therapeutic decisions.

The main feature of all well-differentiated NETs is the overexpression of the somatostatin receptor, measured by PCR-based or immunohistochemistry (IHC)-based methods or by imaging. Among these receptors, the SSTR2A subtype is the most commonly expressed. Diagnostic and therapeutic approaches aimed at SSTR have shown advantages but it is not clear how much the degree of expression of SSTR in positive patients influences the response to treatment and whether it has a correlation with survival, regardless of the oncological treatments used. Furthermore, since the expression of this receptor appears inversely proportional to the degree of differentiation and can be different within the same disease between primary tumor and metastatic disease, this receptor could have a further role as a measure of tumor heterogeneity and disease progression.

Observational Study on GEP-and Pulm-NET Treated at FPG

Observational Study on Clinical, Laboratory, Anatomopathological and Molecular Characteristics and Their Prognostic and Predictive Value in Patients With Neuroendocrine Tumors of the Gastroenteropancreatic Tract and Pulmonary Treated at Fondazione Policlinico Agostino Gemelli (FPG)-IRCCS

The length of time from the date of diagnosis to death.

The length of time from the date of diagnosis to disease progression.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.	NCT04276597	Pulmonary Neuro... Pheochromocytom... Paraganglioma Thymus Carcinoi... Unknown Primary... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	177Lu-DOTATOC	18 Years -	Excel Diagnostics and Nuclear Oncology Center
Observational Study on GEP-and Pulm-NET Treated at FPG	NCT06402695	Neuroendocrine ... Gep Net Pulmonary Neuro...		18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Observational Study on GEP-and Pulm-NET Treated at FPG	NCT06402695	Neuroendocrine ... Gep Net Pulmonary Neuro...		18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.	NCT04276597	Pulmonary Neuro... Pheochromocytom... Paraganglioma Thymus Carcinoi... Unknown Primary... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	177Lu-DOTATOC	18 Years -	Excel Diagnostics and Nuclear Oncology Center

Spots Global Cancer Trial Database for pulmonary neuroendocrine neoplasm