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

Recruiting now · Phase 2/Phase 3

Conditions studied: Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Neoplasm

In brief

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.

Key facts

Study ID

NCT06855095

Run by

The Netherlands Cancer Institute

People needed

39

Starts

2024-06-25

Expected to finish

2027-03-01

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).

Where it is running

• Antoni van Leeuwenhoek — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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