LOS ANGELES, California, June 1, 2026
ITM Isotope Technologies Munich SE announced new findings from its Phase 3 COMPETE trial showing that single-timepoint dosimetry may accurately estimate radiation exposure in patients treated with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, the analysis suggests that population-based modeling could significantly reduce imaging requirements while maintaining accurate individualized dosimetry assessments, potentially simplifying radiopharmaceutical treatment workflows across clinical settings.
Population-Based Modeling Delivers Accurate Dose Estimates
The analysis utilized data from the Phase 3 COMPETE trial, including 207 kidney datasets and 154 tumor datasets collected through planar and SPECT/CT imaging. Investigators evaluated the performance of the PBMS NLMEM modeling approach against established single-timepoint dosimetry methods. Results showed that the model accurately estimated absorbed radiation doses in both kidneys and tumors using only one imaging session, achieving mean absolute percentage error (MAPE) values between 3% and 20% for kidney dosimetry. The PBMS NLMEM approach consistently outperformed comparator methods, supporting the possibility of obtaining reliable personalized dosimetry data from a single scan approximately six hours after treatment administration.
Findings Could Expand Access to Personalized Radiopharmaceutical Therapy
Researchers noted that the simplified approach could help overcome a major barrier to routine implementation of individualized dosimetry, which traditionally requires multiple imaging sessions and significant clinical resources. According to investigators, the ability to perform accurate dosimetry from a single scan may reduce patient burden, streamline clinical workflows, and improve access for treatment centers with limited imaging capacity. Dr. Deni Hardiansyah, Associate Professor at the University of Indonesia and study co-author, stated that the findings demonstrate how population-based modeling could make personalized dosimetry more practical for routine clinical use while maintaining accuracy in dose estimation.
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COMPETE Trial Reinforces ITM-11’s Precision Oncology Potential
The new dosimetry findings build on previously reported Phase 3 COMPETE results, where 177Lu-edotreotide (ITM-11) achieved a statistically significant improvement in progression-free survival (23.9 months versus 14.1 months) compared with everolimus in patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs. ITM Chief Medical Officer Dr. Celine Wilke said the analysis reflects the company’s commitment to advancing precision radiopharmaceutical therapy by making individualized treatment planning more accessible and efficient. ITM is also evaluating ITM-11 in the ongoing Phase 3 COMPOSE study for patients with well-differentiated Grade 2 and Grade 3 somatostatin receptor-positive GEP-NETs. The company believes the simplified dosimetry approach could help broaden adoption of personalized radiopharmaceutical treatments while supporting improved patient care and clinical outcomes.
Source: ITM press release
