Study of Lutetium-177 DOTATATE Dosage Based on Individualized Imaging for Treating Adults with Neuroendocrine Tumors

What this Trial Is About

Researchers are studying whether adjusting the dose of Lutetium-177 DOTATATE Lutathera based on individual dosimetry improves treatment results for adults with unresectable neuroendocrine tumors. This randomized controlled trial compares the standard fixed dose with a customized dosing approach guided by tumor and organ uptake, aiming to evaluate if personalized treatment can enhance outcomes. The study is sponsored by the University of Iowa and involves patients with well-differentiated gastroenteropancreatic neuroendocrine tumors. Participants will receive Lutathera through an intravenous infusion every 8 weeks for up to four cycles. The first dose is fixed at 200 millicuries for all participants. Those in the investigational group may receive higher doses up to 400 millicuries in subsequent cycles based on dosimetry imaging that tracks radiation exposure to tumors, kidneys, and bone marrow. The standard group continues with 200 millicuries per cycle. Imaging such as SPECTCT scans and blood tests are performed to monitor the distribution and effects of the treatment. During the study, participants will undergo PETCT scans before treatment, blood tests for several weeks after each Lutathera dose, and complete questionnaires about their health and symptoms. Follow-up visits occur about every 8 weeks during treatment and at 2, 3, 6, and 12 months after the last cycle. Long-term monitoring continues to assess side effects and treatment outcomes, including CT scans at 6 months and lifelong follow-up for radiation-related effects. The main outcome measure is the tumor response rate 6 months after treatment.

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry