Clinical trial · Observational
A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies
A Prospective and Head-to-head Comparison of [68Ga] Ga-DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies: NET-COMPARE 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)
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medullary Thyroid Carcinoma | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
| Neuroendocrine Tumors, NET | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.85 |
| Pheochromocytoma/Paraganglioma | — | UNRESOLVED | — |
| SSTR-expressing Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-AmBF3-TATE PET/CT | Diagnostic Test | — | UNRESOLVED |
| 68Ga-DOTATATE PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PET/CT Diagnostic Imaging
- description
- Each subject will have two PET/CT scans, one using 68Ga-DOTATATE and the other using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 68Ga-DOTATATE is considered standard care and has been approved by Health Canada.
- interventionNames
- Diagnostic Test: 68Ga-DOTATATE PET/CT
- Diagnostic Test: 18F-AmBF3-TATE PET/CT
Primary outcomes (1)
- measure
- Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE
- timeFrame
- Periprocedural
- description
- To assess the non-inferiority of \[18F\]AmBF3TATE compared to the standard-of-care \[68Ga\]DOTATATE
Secondary outcomes (5)
- measure
- Number of patients in whom one or more target lesions are detected by the core readers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Patients referred for and meeting institutional criteria for a \[68Ga\]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A). Exclusion Criteria: * Pregnant and breast-feeding patients. * Patients unwilling or unable to undergo a second PET/CT. * Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).
References
Publications (0)
Data not yet available