Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)

Inclusion Criteria

• •1\. Age ≥18 years, of both sexes, of any ethnicity;
• •2\. Cyto-histological and immunohistochemical diagnosis of NET;
• •3\. Evaluation of the cell proliferation index by studying Ki-67 and / or E3 ubiquitin-protein ligase (MIB-1).
• •4\. Illness measurable according to RECIST 1.1 criteria by imaging conventional (CT with contrast medium or MRI with contrast medium) not earlier than two months with respect to enrollment;
• •5\. Elevated expression of somatostatin receptors documented by PET-CT with 68Ga-DOTATOC in the target lesion (s). It is defined as "high expression of somatostatin receptors "a ratio of Maximum standardized uptake value (SUVmax) lesion / Mean standardized uptake value (SUVmean) muscle ≥ 4: 1 calculated with semi-quantitative analysis on examination PET-CT with 68Ga-DOTATOC;
• •6\. Dosage of Chromogranin A (and any other specific markers) not prior to two months of enrollment;
• •7\. Evaluation of glucose metabolism in the target lesion (s) by PET-CT with 18F-FDG;
• •8\. Preserved haematological, hepatic and renal parameters, in particular: white blood cells ≥2500 / μL; platelets ≥ 90000 / μL; hemoglobin ≥ 9 gr / dL; creatinine ≤ 2 mg / dL; bilirubin ≤ 2.5 mg / dL
• •9\. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
• •10\. Life expectancy ≥ 6 months;
• •11\. Stable or progressive disease, at any stage, both in operated patients that inoperable;
• •12\. Absence of standard treatments already documented and of equal effectiveness;
• •13\. Absence of surgical, chemotherapy and / or radiotherapy treatments for at least 30 days. On the other hand, patients in therapy with somatostatin analogues or biologics, such as mechanistic target of rapamycin (m-TOR) inhibitors;
• •14\. Voluntary participation in the study by signing the consent form informed, after reading and complete understanding of the information notes.