AminoMedixTM for Kidney Protection During Radionuclide Therapy

Inclusion criteria

• Patients with neuroendocrine tumors are eligible to be recruited in this project.
• Signed informed consent.
• Patients of either gender, age 18 years or older.
• Na+, K+, Cl,: within normal range
• eGFR: > 50 mL/min
• Serum creatinine: <150μmol/L. Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
• Negative pregnancy test (urine test or beta-HCG) in women capable of child-bearing.

Exclusion criteria

• Known hypersensitivity to Amifostine, Lysine, Arginine, DOTA, 68Gallium, to DOTATATE or to any of the excipients of 68Ga-DOTATATE.
• Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
• Pregnant or breast-feeding women.
• Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
• Pre-existing cardiovascular or cerebrovascular conditions such as congestive heart failure, ischemic heart disease, arrhythmias, or a history of stroke or transient ischemic attacks.
• Uncontrolled kidney disease and patients who are under dialysis.
• Current treatment with potentially nephrotoxic drugs such as aminoglycosides.
• Less than 24 hours of withdrawal of antihypertensive medications or uncontrolled hypertension, and diabetes at the time of the study.
• Patients under total or partial parenteral nutrition.