Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2) (FENET-2016)

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Neuroendocrine Tumors, 90Y, 177Lu, PRRT Read More

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.

Exclusion Criteria:

• 1. Lack of the requirements listed above;
• 2. State of pregnancy;
• 3. Breastfeeding and relative refusal to suspend breastfeeding;
• 4. Participation in another therapeutic experimental clinical protocol in the four weeks prior to the PRRT;
• 5. Bone marrow invasion of disease> 25% confirmed;
• 6. Previous extensive radiotherapy treatments.