drugset / Trial / NCT04552847
Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors
Phase 2/3
Completed
85 enrolled
Universitaire Ziekenhuizen KU Leuven
NETwerk, Belgium · collabUniversity Hospital, Antwerp · collabUniversity Hospital, Ghent · collab
NaSingle-groupOpen-labelDiagnostic
Summary
The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-somatostatin analog PET, in neuroendocrine tumor patients.
Timeline
- Start
- 2020-10-07
- Primary completion
- 2022-02-08
- Completion
- 2022-02-08
Outcome
Met primary endpoint
paper The resulting mean DDR was 15.8%, with a lower margin of the 95% CI (95% CI, 9.6%-22.0%) higher than -15% PMID 36265911 ↗
paper Conclusion: 18F-AlF-OC is noninferior and even superior to 68Ga-DOTATATE/NOC PET in NET patients. PMID 36265911 ↗
Publications
- Background Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Dekervel J, Van Cutsem E, Verslype C, Van Laere K, Bormans G, Deroose CM. [18F]AlF-NOTA-octreotide PET imaging: biodistribution, dosimetry and first comparison with [68Ga]Ga-DOTATATE in neuroendocrine tumour patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3033-3046. doi: 10.1007/s00259-020-04918-4. Epub 2020 Jul 2.
- Leupe H, Pauwels E, Vandamme T, Van den Broeck B, Lybaert W, Dekervel J, Van Herpe F, Jaekers J, Cleeren F, Hofland J, Brouwers A, Koole M, Bormans G, Van Cutsem E, Geboes K, Laenen A, Verslype C, Stroobants S, Deroose CM. Clinical impact of using [18F]AlF-NOTA-octreotide PET/CT instead of [68Ga]Ga-DOTA-SSA PET/CT: Secondary endpoint analysis of a multicenter, prospective trial. J Neuroendocrinol. 2024 Aug;36(8):e13420. doi: 10.1111/jne.13420. Epub 2024 Jun 4.
- Boeckxstaens L, Pauwels E, Vandecaveye V, Deckers W, Cleeren F, Dekervel J, Vandamme T, Serdons K, Koole M, Bormans G, Laenen A, Clement PM, Geboes K, Van Cutsem E, Nackaerts K, Stroobants S, Verslype C, Van Laere K, Deroose CM. 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.
- Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Boeckxstaens L, Dekervel J, Vandamme T, Lybaert W, den Broeck BV, Laenen A, Clement PM, Geboes K, Cutsem EV, Stroobants S, Verslype C, Bormans G, Deroose CM. 18F-AlF-NOTA-Octreotide Outperforms 68Ga-DOTATATE/NOC PET in Neuroendocrine Tumor Patients: Results from a Prospective, Multicenter Study. J Nucl Med. 2023 Apr;64(4):632-638. doi: 10.2967/jnumed.122.264563. Epub 2022 Oct 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Al18F-NOTA-octreotide | Diagnostic / imaging agent | 4 mbq/kg | Intravenous |