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Theranostics 2024; 14(8):3213-3220. doi:10.7150/thno.96762 This issue Cite

Research Paper

Diagnostic performance and clinical impact of ¹⁸F-AlF-NOTA-octreotide in a large cohort of patients with neuroendocrine neoplasms: A prospective single-center study

Guozhu Hou^1#, Xin Cheng^1#, Yi Yang^2#, Dongbing Zhao³, Guiqi Wang⁴, Hong Zhao², Rong Zheng^1✉, Xuejuan Wang^1✉, Xiaoyuan Chen^{5,6,7,8,9,10✉}, Yihebali Chi^11✉, Jingjing Zhang^5,6,7,8✉

1. Department of Nuclear Medicine (PET-CT Center), National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
2. 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, China.
3. Department of Pancreatic and Gastric Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
4. Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
5. Department of Diagnostic Radiology, Yong Loo Lin School of Medicine and Faculty of Engineering, National University of Singapore, Singapore.
6. Clinical Imaging Research Centre, Centre for Translational Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
7. Theranostics Center of Excellence (TCE), Yong Loo Lin School of Medicine, National University of Singapore, 11 Biopolis Way, Helios, Singapore 138667
8. Nanomedicine Translational Research Program, NUS Center for Nanomedicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
9. Departments of Surgery, Chemical and Biomolecular Engineering, and Biomedical Engineering, Yong Loo Lin School of Medicine and College of Design and Engineering, National University of Singapore, Singapore
10. Institute of Molecular and Cell Biology, Agency for Science, Technology, and Research (A*STAR, National University of Singapore, 61 Biopolis Drive, Proteos, Singapore, Singapore
11. Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
# Contributed equally to this work.

✉ Corresponding authors: Rong Zheng, E-mail: zrong99com; Xuejuan Wang, E-mail: xuejuan_wangcom; Xiaoyuan Chen, E-mail: chen.shawnedu.sg; Yihebali Chi, E-mail: yihebalichicom; Jingjing Zhang, E-mail: j.zhangedu.sg.

Abstract

Purpose: Somatostatin receptor imaging with ¹⁸F-AlF-NOTA-octreotide (¹⁸F-AlF-OC) has shown promising performance in neuroendocrine neoplasms (NENs). In this study, we aim to investigate the diagnostic performance and clinical impact of ¹⁸F-AlF-OC in a large prospective cohort of patients with NEN.

Methods: Between January 2023 and November 2023, a total of 219 patients with confirmed or suspected NEN were enrolled prospectively and underwent ¹⁸F-AlF-OC PET/CT at 2 h post-injection. The primary endpoint was the diagnostic performance, including sensitivity, specificity, and accuracy. An additional primary endpoint was the impact of ¹⁸F-AlF-OC on clinical management. The reference standard was based on the results of histopathology or radiological follow-up.

Results: 205 patients were included in the final analysis. The patient-level sensitivity, specificity, and accuracy of ¹⁸F-AlF-OC PET/CT compared with contrast-enhanced CT/MRI were 90.5% vs. 81.8%, 93.1% vs. 71.1%, and 91.2% vs. 79.4%, respectively. 26 patients had tiny gastrointestinal NENs (smaller than 1 cm in diameter). The patient-based sensitivity of ¹⁸F-AlF-OC PET/CT and contrast-enhanced CT/MRI were 61.5% (16/26) and 37.5% (9/24), respectively. The smallest diameter of gastrointestinal NEN detected by ¹⁸F-AlF-OC PET/CT was 0.6 cm in the rectum, 0.3 cm in the stomach, and 0.5 cm in the duodenum. ¹⁸F-AlF-OC PET/CT results led to changes in clinical management in 19.5% of patients (40/205), owing mainly to new or unexpected findings compared to contrast-enhanced CT/MRI.

Conclusion: ¹⁸F-AlF-OC PET/CT demonstrated great diagnostic performance in patients with NEN, particularly for detecting tiny gastrointestinal NEN. Furthermore, ¹⁸F-AlF-OC PET/CT impacted the therapeutic management in 19.5% of patients. Our results further validate the role of ¹⁸F-AlF-OC as a somatostatin receptor imaging tracer in clinical practice.

Keywords: neuroendocrine neoplasms (NENs), ¹⁸F-AlF-OC, PET/CT, somatostatin receptors (SSTRs), clinical practice, contrast-enhanced CT/MRI

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