NCT06855095 Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
| NCT ID | NCT06855095 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Neuroendocrine Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2027-01-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Able to provide spoken and written informed consent for the trial; * Histopathological confirmed neuroendocrine tumor; * Fulfill the clinical criteria for PRRT; * At least one soft tissue lesion \> 2 cm; * Aimed administered activity of 7400 MBq; * ECOG score (performance status) 0-2. Exclusion Criteria: * Not possible to discontinue LA-SSA for 4-6 weeks; * Use of short-acting SSAs; * Pregnancy and lactating female patients; * Inability to comply to the study procedures; * Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).