RecruitingPhase 2Phase 3NCT06855095

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

Sponsor

The Netherlands Cancer Institute

Enrollment

39 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

Neuroendocrine Neoplasm Neuroendocrine Tumors Neuroendocrine Tumor Grade 1 Neuroendocrine Tumor Grade 2

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria5

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.).

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