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Clinical Trials in the Netherlands / NCT06855095
Recruiting Phase 2/3

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

NCT06855095 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2/3
Started
2024-06-25
Last updated
2025-03-03

Condition(s) studied

Neuroendocrine TumorsNeuroendocrine Tumor Grade 1Neuroendocrine Tumor Grade 2Neuroendocrine Neoplasm

Investigational drug(s) / intervention(s)

Somatostatin analog

Somatostatin analog: Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Antoni van Leeuwenhoek Amsterdam Netherlands Recruiting

More The Netherlands Cancer Institute trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855095 on ClinicalTrials.gov ↗ ← All trials in the Netherlands