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

Last updated: February 26, 2025
Sponsor: The Netherlands Cancer Institute
Overall Status: Active - Recruiting

Phase

2/3

Condition

Neoplasms

Abdominal Cancer

Digestive System Neoplasms

Treatment

Somatostatin analog

Clinical Study ID

NCT06855095
N23PRR
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

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 forfurosemide directly after PRRT infusion, limited fluid intake, any renal catheters,etc.).

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: Somatostatin analog
Phase: 2/3
Study Start date:
June 25, 2024
Estimated Completion Date:
March 01, 2027

Study 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.

Connect with a study center

  • Antoni van Leeuwenhoek

    Amsterdam,
    Netherlands

    Active - Recruiting

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