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

Phase 2

Recruiting

• Conditions: Neuroendocrine Tumors; Neuroendocrine Tumor Grade 1; Neuroendocrine Tumor Grade 2; Neuroendocrine Neoplasm
• Interventions: Drug: Somatostatin analog

• Registration Number: NCT06855095
• Lead Sponsor: The Netherlands Cancer Institute

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.

Detailed Description

The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.

Study Timeline

• Study First Submitted: 2023-10-25
• Study Start: 2024-06-25
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2027-01-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2A - LA-SSA injection 4-6 weeks before PRRT	Somatostatin analog	In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.
2B - LA-SSA injection 1-7 days before PRRT	Somatostatin analog	In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.

Primary Outcome Measures

Name	Time	Method
Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.	SPECT/CT after 4h, 24h, and 5-7 days post-injection

Secondary Outcome Measures

Name	Time	Method
Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.	SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection
Effect of continued LA-SSA use on the tumor-to-background ratio.	SPECT/CT after 4h, 24h, and 5-7 days post-injection
Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.	Blood samples at 2h, 4h, 24h and 5-7 days post-injection

Trial Locations

Locations (1)

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, Netherlands