Study of Tumor Absorbed Dose in Peptide Receptor Radionuclide Therapy for Adults with Neuroendocrine Tumors Using Long-acting Somatostatin Analogues

What this Trial Is About

Researchers are investigating the impact of long-acting somatostatin analogues LA-SSA on the absorbed radiation dose in tumor lesions during peptide receptor radionuclide therapy PRRT for patients with neuroendocrine tumors grade I and II. The study explores whether continuing or stopping LA-SSA treatment before PRRT affects tumor radiation absorption, following current guidelines that recommend withholding LA-SSA 4-6 weeks before PRRT administration. Participants are randomized into three groups one group has not received LA-SSA treatment for at least three months before PRRT, the second group discontinues LA-SSA 4-6 weeks before PRRT, and the third group receives PRRT within one week after their most recent LA-SSA injection. The treatment involves administering 177Lutetium-DOTATATE with scheduled imaging and blood sample collections to assess drug effects and radiation dose. During the trial, participants undergo SPECTCT scans at 4 hours, 24 hours, and between 5 to 7 days after injection to measure absorbed doses in tumors and normal tissues. Blood samples are also collected at multiple timepoints to study pharmacokinetics. Researchers monitor clinical status and performance scores, with the primary outcome focusing on tumor radiation absorption. The study runs until March 2027, with careful follow-up to evaluate treatment impact and safety.

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