Clinical trial · Interventional
Comparison of Al18F-NOTA-LM3 With 68Ga-DOTATATE and 68Ga-NODAGA-LM3 PET/CT in Patients With Well-differentiated Neuroendocrine Tumors
Evaluation of Biodistribution, Dosimetry, Diagnostic Ability, and Safety of Al18F-NOTA-LM3 in Patients With Well-differentiated Neuroendocrine Tumors, and Comparison With 68Ga-DOTATATE and 68Ga-NODAGA-LM3: A Prospective, Single-center, Double-blinded Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective, single-center, double-blinded study investigates the biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compares the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management will also be compared using different imaging modalities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTATATE | Diagnostic Test | — | UNRESOLVED |
| 68Ga-NODAGA-LM3 | Diagnostic Test | — | UNRESOLVED |
| Al18F-NOTA-LM3 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group
- description
- Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT.
- interventionNames
- Diagnostic Test: Al18F-NOTA-LM3
- Diagnostic Test: 68Ga-DOTATATE
- type
- EXPERIMENTAL
- label
- Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group
- description
- Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-NODAGA-LM3 PET/CT.
- interventionNames
- Diagnostic Test: Al18F-NOTA-LM3
- Diagnostic Test: 68Ga-NODAGA-LM3
Primary outcomes (7)
- measure
- Safety of Al18F-NOTA-LM3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 to 80 years. * Histologically proven, well-differentiated, NETs (G1 or G2). * No long-acting somatostatin analog treatment within 4 weeks. * No PRRT treatment within 8 weeks. Exclusion Criteria: * Combined with other types of tumors. * Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR\<30ml/min). * Active infection. * Pregnant or breast-feeding women. * Inability to perform PET/CT scans.
References
Publications (2)
- DERIVEDLiu M, Zhang Y, Yan X, Zhang H, Ren C, Huang Z, Cheng Y, Xu Q, Li Y, Jia R, Zhu W, Huo L. Assessment of the diagnostic efficacy and clinical significance of [18F]AlF-NOTA-LM3 PET/CT in patients with well-differentiated neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2026 Jan;53(2):954-967. doi: 10.1007/s00259-025-07484-9. Epub 2025 Aug 5. PMID 40762797
- DERIVEDLiu M, Ren C, Zhang H, Zhang Y, Huang Z, Jia R, Cheng Y, Bai C, Xu Q, Zhu W, Huo L. Evaluation of the safety, biodistribution, dosimetry of [18F]AlF-NOTA-LM3 and head-to-head comparison with [68Ga]Ga-DOTATATE in patients with well-differentiated neuroendocrine tumors: an interim analysis of a prospective trial. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3719-3730. doi: 10.1007/s00259-024-06790-y. Epub 2024 Jun 15. PMID 38878175