2. Academic Validation
  3. A prospective randomized, double-blind study to evaluate the diagnostic efficacy of 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 in patients with well-differentiated neuroendocrine tumors: compared with 68Ga-DOTATATE

A prospective randomized, double-blind study to evaluate the diagnostic efficacy of 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 in patients with well-differentiated neuroendocrine tumors: compared with 68Ga-DOTATATE

  • Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1613-1622. doi: 10.1007/s00259-021-05512-y.
Wenjia Zhu 1,  Ru Jia 2,  Qiao Yang 1,  Yuejuan Cheng 3,  Hong Zhao 4,  Chunmei Bai 3,  Jianming Xu 2,  Shaobo Yao 5,  Li Huo 6
Affiliations

Affiliations

  • 1 Department of Nuclear Medicine, Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
  • 2 Department of Gastrointestinal Oncology, the Fifth Medical Center, General Hospital of PLA, No. 8, East Avenue, Fengtai District, Beijing, China.
  • 3 Department of Oncology, Peking Union Medical College Hospital, Beijing, 100730, China.
  • 4 Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
  • 5 Department Nuclear Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, Fujian, China.
  • 6 Department of Nuclear Medicine, Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. huoli@pumch.cn.
PMID: 34874478 DOI: 10.1007/s00259-021-05512-y
Abstract

Purpose: The purpose of this study is to evaluate the diagnostic efficacy of 68 Ga-NODAGA-LM3 and 68 Ga-DOTA-LM3 and compare them with 68 Ga-DOTATATE in patients with well-differentiated neuroendocrine tumors.

Methods: Patients were prospectively recruited and equally randomized into two arms: Arm A, patients would undergo a whole-body 68 Ga-NODAGA-LM3 PET/CT scan on the 1st day and 68 Ga-DOTATATE PET/CT scan on the 2nd day; Arm B, patients would undergo a whole-body 68 Ga-DOTA-LM3 PET/CT scan on the 1st day and 68 Ga-DOTATATE PET/CT scan on the 2nd day. Biodistribution in normal organs, lesion detection ability, and tumor uptake were compared between antagonist and agonist in each arm.

Results: A total of 40 patients with well-differentiated NETs, 20 in each arm, were recruited in the study. 68 Ga-NODAGA-LM3 showed a similar pattern as 68 Ga-DOTATATE, while 68 Ga-DOTA-LM3 demonstrated significantly lower uptake in almost all normal organs compared to 68 Ga-DOTATATE. Both 68 Ga-NODAGA-LM3 and 68 Ga-DOTA-LM3 showed superiority in lesion detection compared to 68 Ga-DOTATATE on lesion-based and patient-based comparison. 68 Ga-NODAGA-LM3 showed a significantly higher tumor uptake (median SUVmax 29.1 versus 21.6, P < 0.05) and tumor-to-background ratio (median tumor-to-liver ratio 5.0 versus 2.9, P < 0.05) compared to 68 Ga-DOTATATE. 68 Ga-DOTA-LM3 showed comparable uptake (median SUVmax 16.1 versus 17.8, P = 0.714) and higher tumor-to-background ratio (median tumor-to-liver ratio 5.2 versus 2.1, P < 0.05).

Conclusion: Both 68 Ga-NODAGA-LM3 and 68 Ga-DOTA-LM3 are promising SSTR2 antagonists for neuroendocrine tumors. They demonstrated superiority in diagnostic efficacy compared to agonist 68 Ga-DOTATATE.

Trial registration: ClinicalTrials.gov identifier: NCT04318561.

Keywords

68 Ga-DOTA-LM3; 68 Ga-DOTATATE; 68 Ga-NODAGA-LM3; Neuroendocrine tumor; Somatostatin receptor antagonist.

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