Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial

Launched by THE NETHERLANDS CANCER INSTITUTE · Feb 26, 2025

Keywords

ClinConnect Summary

The ATSA Trial is a clinical study looking at how a specific treatment, called Peptide Receptor Radionuclide Therapy (PRRT), works for patients with neuroendocrine tumors, which are a type of cancer. The main goal of this trial is to see how a long-acting medication, called somatostatin analogues (LA-SSA), affects the amount of radiation absorbed by the tumors during treatment. Currently, patients need to stop using LA-SSA for 4 to 6 weeks before receiving PRRT, and this study aims to understand the impact of that break on treatment effectiveness.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of a neuroendocrine tumor. You should also have at least one tumor that is larger than 2 centimeters. Participants will need to be able to give consent for the study and have a performance status that indicates they can engage in daily activities. If you are currently using short-acting somatostatin medications, are pregnant or breastfeeding, or have certain health issues that may interfere with the study, you may not be eligible. If you qualify, you can expect to undergo treatment and monitoring to help researchers learn more about the best ways to use this therapy for better patient outcomes.

Gender

ALL

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.).