Liu Meixi, Zhang Yuwei, Yan Xinchun, Zhang Haiqiong, Ren Chao, Huang Zhenghai, Cheng Yuejuan, Xu Qiang, Li Yatong, Jia Ru, Zhu Wenjia, Huo Li
Department of Nuclear Medicine, State Key Laboratory of Complex, Severe, and Rare Diseases, Center for Rare Diseases Research, Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
Theranostics and Translational Research Center, National Infrastructures for Translational Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Eur J Nucl Med Mol Imaging. 2025 Aug 5. doi: 10.1007/s00259-025-07484-9.
This study aimed to compare the diagnostic efficacy and clinical management impact of [F]AlF-NOTA-LM3 with [Ga]Ga-DOTATATE or [Ga]Ga-NODAGA-LM3 in patients with well-differentiated neuroendocrine tumors.
Patients with histologically confirmed well-differentiated NETs were prospectively recruited and randomized into two arms: Arm A, undergo [F]AlF-NOTA-LM3 and [Ga]Ga-DOTATATE PET/CT; Arm B, undergo [F]AlF-NOTA-LM3 and [Ga]Ga-NODAGA-LM3 PET/CT. Biodistribution, lesion numbers, and lesion uptake were compared. The impact on clinical management was evaluated. Additionally, a post-hoc analysis of the sensitivity of [F]AlF-NOTA-LM3 and Ga-labeled tracers was evaluated.
A total of 78 patients were included in this study: 38 in Arm A and 40 in Arm B. [F]AlF-NOTA-LM3 showed lower abdominal organ uptake than [Ga]Ga-DOTATATE and [Ga]Ga-NODAGA-LM3. [F]AlF-NOTA-LM3 was superior to [Ga]Ga-DOTATATE in liver (684 vs. 449, P<0.001) and lymph node lesion (41 vs. 29, P = 0.005) detection, and superior to [Ga]Ga-NODAGA-LM3 in liver lesion (625 vs. 490, P = 0.001) detection. The lesion-level sensitivity of [F]AlF-NOTA-LM3 was significantly higher than that of [Ga]Ga-DOTATATE (90.6% vs. 67.6%, P<0.001) and [Ga]Ga-NODAGA-LM3 (90.9% vs. 81.0%, P<0.001), particularly for liver metastases. [F]AlF-NOTA-LM3 led to a clinical management change in 18.5% (7/38) of patients in Arm A and 12.5% (5/40) of patients in Arm B: 13.2% (5/38) in Arm A and 7.5% (3/40) in Arm B with major changes, while 5.3% (2/38) in Arm A and 5% (2/40) in Arm B with minor changes.
[F]AlF-NOTA-LM3 shows superior diagnostic efficacy than [Ga]Ga-DOTATATE and [Ga]Ga-NODAGA-LM3. [F]AlF-NOTA-LM3 demonstrates significant value in guiding clinical decision-making in a subgroup of patients.
ClinicalTrials.gov identifier NCT06056362.
本研究旨在比较[F]AlF-NOTA-LM3与[Ga]Ga-DOTATATE或[Ga]Ga-NODAGA-LM3在高分化神经内分泌肿瘤患者中的诊断效能及对临床管理的影响。
前瞻性招募经组织学确诊的高分化神经内分泌肿瘤患者，并随机分为两组：A组，接受[F]AlF-NOTA-LM3和[Ga]Ga-DOTATATE PET/CT检查；B组，接受[F]AlF-NOTA-LM3和[Ga]Ga-NODAGA-LM3 PET/CT检查。比较两组的生物分布、病灶数量及病灶摄取情况。评估对临床管理的影响。此外，对[F]AlF-NOTA-LM3和镓标记示踪剂的敏感性进行事后分析。
本研究共纳入78例患者，A组38例，B组40例。[F]AlF-NOTA-LM3的腹部脏器摄取低于[Ga]Ga-DOTATATE和[Ga]Ga-NODAGA-LM3。在肝脏（684对449，P<0.001）和淋巴结病灶（41对29，P = 0.005）检测方面，[F]AlF-NOTA-LM3优于[Ga]Ga-DOTATATE；在肝脏病灶（625对490，P = 0.001）检测方面，[F]AlF-NOTA-LM3优于[Ga]Ga-NODAGA-LM3。[F]AlF-NOTA-LM3的病灶水平敏感性显著高于[Ga]Ga-DOTATATE（90.6%对67.6%，P<0.001）和[Ga]Ga-NODAGA-LM3（90.9%对81.0%，P<0.001），尤其是对肝转移灶。[F]AlF-NOTA-LM3使A组18.5%（7/38）的患者和B组12.5%（5/40）的患者临床管理发生改变：A组13.2%（5/38）和B组7.5%（3/40）为重大改变，A组5.3%（2/38）和B组5%（2/40）为微小改变。
[F]AlF-NOTA-LM3显示出比[Ga]Ga-DOTATATE和[Ga]Ga-NODAGA-LM3更高的诊断效能。[F]AlF-NOTA-LM3在指导部分患者的临床决策方面具有重要价值。
ClinicalTrials.gov标识符NCT06056362。
