European journal of nuclear medicine and molecular imaging · 2025
Head-to-Head comparison of [18F]AlF-NOTA-TATE and [68Ga]Ga-DOTA-TATE PET/CT in patients with neuroendocrine tumors: a prospective study.
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Liu Huanhuan, Ma Guangyu, Wen Hui, Xu Xiaodan, Wu Shina, Wang Yuan, Pan Yue, Zhang Cong, Zhang Jingfeng, Liu Yachao, Dong Yanliang, Dong Zhouhuan, Zhang Xiaojun, Wang Ruimin, Zhang Jinming
Аннотация
OBJECTIVE: A prospective comparison was conducted between [¹⁸F]AlF-NOTA-TATE and the routinely used clinical imaging agent [⁶⁸Ga]Ga-DOTA-TATE in patients with neuroendocrine tumors (NETs) to evaluate diagnostic performance, pharmacokinetic characteristics, and safety. Additionally, the clinical potential of [¹⁸F]AlF-NOTA-TATE as an alternative imaging agent was explored.
METHODS: [¹⁸F]AlF-NOTA-TATE was synthesized automatically using a self-developed direct purification technology based on column chromatography, with strict adherence to quality control standards. A clinical comparative study enrolled 20 patients with suspected or confirmed neuroendocrine tumors (NETs) (median age: 52 years). All patients underwent PET/CT imaging with both [¹⁸F]AlF-NOTA-TATE (7.8 ± 1.8 mCi) and [⁶⁸Ga]Ga-DOTA-TATE (3.9 ± 0.6 mCi) within a 3-day interval. Image analysis included evaluation of parameters such as lesion detection rate, maximum standardized uptake value (SUVmax), and tumor-to-background ratio (TBR). In parallel, radiation dosimetry and biodistribution characteristics were also assessed.
RESULTS: Among the 20 patients, 13 were diagnosed with NETs, 4 exhibited negative imaging findings, and 3 had non-NET lesions. Biodistribution analysis revealed that [¹⁸F]AlF-NOTA-TATE showed higher physiological uptake in normal organs such as the pituitary gland and spleen compared to [⁶⁸Ga]Ga-DOTA-TATE, but lower uptake in the brain and blood pool. The overall lesion detection rates of [¹⁸F]AlF-NOTA-TATE and [68Ga]Ga-DOTA-TATE in pancreas, liver, lymph nodes and bone metastases were consistent; however, [¹⁸F]AlF-NOTA-TATE demonstrated significantly higher uptake in liver metastases (SUVmax: 63.9 ± 24.9 vs. 37.2 ± 6.2, P = 0.009), lymph node metastases (median SUVmax: 33.8 vs. 22.4, P = 0.021), and bone metastases (SUVmax: 112.9 ± 20.7 vs. 66.1 ± 6.7, P < 0.001). In terms of tumor-to-background ratio (TBR), [¹⁸F]AlF-NOTA-TATE also outperformed [⁶⁸Ga]Ga-DOTA-TATE for liver lesions (77.8 ± 32.4 vs. 57.3 ± 17.6, P = 0.040) and bone metastases (135.2 ± 28.6 vs. 89.3 ± 18.9, P = 0.001). Dosimetry analysis indicated an effective dose of 0.021 ± 0.007 mSv/MBq, with the spleen receiving the highest absorbed dose (0.109 ± 0.059 mGy/MBq), and confirmed good safety.
CONCLUSION: [¹⁸F]AlF-NOTA-TATE demonstrated a comparable lesion detection rate to [⁶⁸Ga]Ga-DOTA-TATE for the diagnosis of neuroendocrine tumors (NETs), while exhibiting higher tumor uptake and superior tumor-to-background ratios (TBR). These results suggest that [¹⁸F]AlF-NOTA-TATE may serve as a promising alternative for the diagnosis of NETs.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2300072266), registered on 8 June 2023.
METHODS: [¹⁸F]AlF-NOTA-TATE was synthesized automatically using a self-developed direct purification technology based on column chromatography, with strict adherence to quality control standards. A clinical comparative study enrolled 20 patients with suspected or confirmed neuroendocrine tumors (NETs) (median age: 52 years). All patients underwent PET/CT imaging with both [¹⁸F]AlF-NOTA-TATE (7.8 ± 1.8 mCi) and [⁶⁸Ga]Ga-DOTA-TATE (3.9 ± 0.6 mCi) within a 3-day interval. Image analysis included evaluation of parameters such as lesion detection rate, maximum standardized uptake value (SUVmax), and tumor-to-background ratio (TBR). In parallel, radiation dosimetry and biodistribution characteristics were also assessed.
RESULTS: Among the 20 patients, 13 were diagnosed with NETs, 4 exhibited negative imaging findings, and 3 had non-NET lesions. Biodistribution analysis revealed that [¹⁸F]AlF-NOTA-TATE showed higher physiological uptake in normal organs such as the pituitary gland and spleen compared to [⁶⁸Ga]Ga-DOTA-TATE, but lower uptake in the brain and blood pool. The overall lesion detection rates of [¹⁸F]AlF-NOTA-TATE and [68Ga]Ga-DOTA-TATE in pancreas, liver, lymph nodes and bone metastases were consistent; however, [¹⁸F]AlF-NOTA-TATE demonstrated significantly higher uptake in liver metastases (SUVmax: 63.9 ± 24.9 vs. 37.2 ± 6.2, P = 0.009), lymph node metastases (median SUVmax: 33.8 vs. 22.4, P = 0.021), and bone metastases (SUVmax: 112.9 ± 20.7 vs. 66.1 ± 6.7, P < 0.001). In terms of tumor-to-background ratio (TBR), [¹⁸F]AlF-NOTA-TATE also outperformed [⁶⁸Ga]Ga-DOTA-TATE for liver lesions (77.8 ± 32.4 vs. 57.3 ± 17.6, P = 0.040) and bone metastases (135.2 ± 28.6 vs. 89.3 ± 18.9, P = 0.001). Dosimetry analysis indicated an effective dose of 0.021 ± 0.007 mSv/MBq, with the spleen receiving the highest absorbed dose (0.109 ± 0.059 mGy/MBq), and confirmed good safety.
CONCLUSION: [¹⁸F]AlF-NOTA-TATE demonstrated a comparable lesion detection rate to [⁶⁸Ga]Ga-DOTA-TATE for the diagnosis of neuroendocrine tumors (NETs), while exhibiting higher tumor uptake and superior tumor-to-background ratios (TBR). These results suggest that [¹⁸F]AlF-NOTA-TATE may serve as a promising alternative for the diagnosis of NETs.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2300072266), registered on 8 June 2023.