Prospective comparison of [18F]AlF-NOTA-octreotide PET/MRI to [68Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients

Lennert Boeckxstaens; Elin Pauwels; Vincent Vandecaveye; Wies Deckers; Frederik Cleeren; Jeroen Dekervel; Timon Vandamme; Kim Serdons; Michel Koole; Guy Bormans; Annouschka Laenen; Paul M Clement; Karen Geboes; Eric Van Cutsem; Kristiaan Nackaerts; Sigrid Stroobants; Chris Verslype; Koen Van Laere; Christophe M Deroose

doi:10.1186/s13550-023-01003-3

Prospective comparison of [¹⁸F]AlF-NOTA-octreotide PET/MRI to [⁶⁸Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients

EJNMMI Res. 2023 Jun 1;13(1):53. doi: 10.1186/s13550-023-01003-3.

Authors

Lennert Boeckxstaens¹, Elin Pauwels¹, Vincent Vandecaveye², Wies Deckers¹, Frederik Cleeren³, Jeroen Dekervel⁴, Timon Vandamme^{5

6}, Kim Serdons¹, Michel Koole¹, Guy Bormans³, Annouschka Laenen⁷, Paul M Clement⁸, Karen Geboes⁹, Eric Van Cutsem⁴, Kristiaan Nackaerts¹⁰, Sigrid Stroobants¹¹, Chris Verslype⁴, Koen Van Laere¹, Christophe M Deroose¹²

Affiliations

¹ Nuclear Medicine, University Hospitals Leuven and Nuclear Medicine and Molecular Imaging,, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium", Campus Gasthuisberg, Nucleaire Geneeskunde, Herestraat 49, 3000, Leuven, Belgium.
² Radiology, Department of Imaging and Pathology, University Hospitals Leuven and Division of Translational MRI, KU Leuven, Leuven, Belgium.
³ Radiopharmaceutical Research, Department of Pharmacy and Pharmacology, KU Leuven, Leuven, Belgium.
⁴ Digestive Oncology, University Hospitals Leuven, Leuven, Belgium.
⁵ Center for Oncological Research (CORE), Integrated Personalized and Precision Oncology Network (IPPON), University of Antwerp, Antwerp, Belgium.
⁶ Oncology, NETwerk Antwerpen-Waasland CoE, Antwerp, Belgium.
⁷ Leuven Biostatistics and Statistical Bioinformatics Center, KU Leuven, Leuven, Belgium.
⁸ General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.
⁹ Digestive Oncology, Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.
¹⁰ Respiratory Oncology, University Hospitals Leuven, Leuven, Belgium.
¹¹ Nuclear Medicine, Faculty of Medicine and Health Sciences, Antwerp University Hospital and Molecular Imaging and Radiology, University of Antwerp, Wilrijk, Belgium.
¹² Nuclear Medicine, University Hospitals Leuven and Nuclear Medicine and Molecular Imaging,, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium", Campus Gasthuisberg, Nucleaire Geneeskunde, Herestraat 49, 3000, Leuven, Belgium. christophe.deroose@uzleuven.be.

Abstract

Background: Fluorine-18-labeled SSAs have the potential to become the next-generation tracer in SSTR-imaging in neuroendocrine tumor (NET) patients given their logistical advantages over the current gold standard gallium-68-labeled SSAs. In particular, [¹⁸F]AlF-OC has already shown excellent clinical performance. We demonstrated in our previous report from our prospective multicenter trial that [¹⁸F]AlF-OC PET/CT outperforms [⁶⁸Ga]Ga-DOTA-SSA, but histological confirmation was lacking due to ethical and practical reasons. In this second arm, we therefore aimed to provide evidence that the vast majority of [¹⁸F]AlF-OC PET lesions are in fact true NET lesions by analyzing their MR characteristics on simultaneously acquired MRI. We had a special interest in lesions solely detected by [¹⁸F]AlF-OC ("incremental lesions").

Methods: Ten patients with a histologically confirmed neuroendocrine tumor (NET) and a standard-of-care [⁶⁸Ga]Ga-DOTATATE PET/CT, performed within 3 months, were prospectively included. Patients underwent a whole-body PET/MRI (TOF, 3 T, GE Signa), 2 hours after IV injection of 4 MBq/kg [¹⁸F]AlF-OC. Positive PET lesions were evaluated for a corresponding lesion on MRI. The diagnostic performance of both PET tracers was evaluated by determining the detection ratio (DR) for each scan and the differential detection ratio (DDR) per patient.

Results: In total, 195 unique lesions were detected: 167 with [⁶⁸Ga]Ga-DOTATATE and 193 with [¹⁸F]AlF-OC. The DR for [¹⁸F]AlF-OC was 99.1% versus 91.4% for [⁶⁸Ga]Ga-DOTATATE, significant for non-inferiority testing (p = 0.0001). Out of these 193 [¹⁸F]AlF-OC lesions, 96.2% were confirmed by MRI to be NET lesions. Thirty-three incremental lesions were identified by [¹⁸F]AlF-OC, of which 91% were confirmed by MRI and considered true positives.

Conclusion: The DR of [¹⁸F]AlF-OC was numerically higher and non-inferior to the DR of [⁶⁸Ga]Ga-DOTATATE. [¹⁸F]AlF-OC lesions and especially incremental lesions were confirmed as true positives by MRI in more than 90% of lesions. Taken together, these data further validate [¹⁸F]AlF-OC as a new alternative for SSTR PET in clinical practice. Trial registration ClinicalTrials.gov: NCT04552847. Registered 17 September 2020, https://beta.

Clinicaltrials: gov/study/NCT04552847.

Keywords: Neuroendocrine tumor; PET; PET/MR; Somatostatin receptor; [18F]AlF-NOTA-octreotide; [68Ga]Ga-DOTATATE.

Associated data

ClinicalTrials.gov/NCT04552847