Al[(18)F]F-NOTA-Octreotide Is Comparable to [(68)Ga]Ga-DOTA-TATE for PET/CT Imaging of Neuroendocrine Tumours in the Latin-American Population

SIMPLE SUMMARY: In the present work we investigated the clinical utility of Al[(18)F]F-NOTA-Octreotide (Al[(18)F]F-OC) in comparison to [(68)Ga]Ga-DOTA-TATE in patients diagnosed with neuroendocrine tumours. Our aim was to verify the recently published, promising results for Al[(18)F]F-NOTA-Octreotide in the Latin-American population. Al[(18)F]F-NOTA-Octreotide provided excellent image quality, detected NET lesions with high sensitivity and represents a highly promising, clinical alternative to [(68)Ga]Ga-DOTA-TATE. ABSTRACT: PET imaging of neuroendocrine tumours (NET) is well established for staging and therapy follow-up. The short half-life, increasing costs, and regulatory issues significantly limit the availability of approved imaging agents, such as [(68)Ga]Ga-DOTA-TATE. Al[(18)F]F-NOTA-Octreotide provides a similar biodistribution and tumour uptake, can be produced on a large scale and may improve access to precision imaging. Here we prospectively compared the clinical utility of [(68)Ga]Ga-DOTA-TATE and Al[(18)F]F-NOTA-Octreotide in the Latin-American population. Our results showed that in patients with stage IV NETs [(68)Ga]Ga-DOTA-TATE presents higher physiological uptake than Al[(18)F]F-NOTA-Octreotide in the liver, hypophysis, salivary glands, adrenal glands (all p < 0.001), pancreatic uncinated process, kidneys, and small intestine (all p < 0.05). Nevertheless, despite the lower background uptake of Al[(18)F]F-NOTA-Octreotide, comparative analysis of tumour-to-liver (TLR) and tumour-to-spleen (TSR) showed no statistically significant difference for lesions in the liver, bone, lymph nodes, and other tissues. Only three discordant lesions in highly-metastases livers were detected by [(68)Ga]Ga-DOTA-TATE but not by Al[(18)F]F-NOTA-Octreotide and only one discordant lesion was detected by Al[(18)F]F-NOTA-Octreotide but not by [(68)Ga]Ga-DOTA-TATE. Non-inferiority analysis showed that Al[(18)F]F-NOTA-Octreotide is comparable to [(68)Ga]Ga-DOTA-TATE. Hence, our results demonstrate that Al[(18)F]F-NOTA-Octreotide provided excellent image quality, visualized NET lesions with high sensitivity and represents a highly promising, clinical alternative to [(68)Ga]Ga-DOTA-TATE.