Clinical trial · Observational
18F-AmBF3-TATE PET/CT for Imaging NET Patients
Evaluation of the Safety and Sensitivity of 18F-AmBF3-TATE PET/CT for Imaging NET Patients
- 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 special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs. This study proposes 18F-AmBF3-TATE positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the biodistribution and safety of 18F-AmBF3-TATE PET/CT for neuroendocrine tumour imaging.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-AmBF3-TATE PET/CT | Diagnostic Test | — | UNRESOLVED |
| Routine blood draw | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PET/CT Diagnostic Imaging
- description
- Each subject will have a PET/CT scan, using 18F-AmBF3-TATE. 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.
- interventionNames
- Diagnostic Test: 18F-AmBF3-TATE PET/CT
- Diagnostic Test: Routine blood draw
Primary outcomes (1)
- measure
- Biodistribution of 18F-AmBF3-TATE PET/CT in human subjects
- timeFrame
- 1 year
- description
- Measurement of radiotracer uptake at multiple time points following radiotracer injection. Calculation of radiation dosimetry using OLINDA 2.0 methodology. Determination of tumour uptake in terms of standardized uptake values and tumour/blood, tumour/liver and tumour/lung ratios (descriptive analysis). For accuracy determination, it is anticipated that only a subset of participants may have a complete gold standard for the determination of accuracy. The sensitivity, specificity and accuracy (along with the confidence interval) of 18F-AMBF3-TATE will be calculated for patients with an available gold standard. The proportion of participants with a complete gold standard is not yet known for this study.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: All subjects: * Participants with newly diagnosed or documented neuroendocrine tumours (NET), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-FDG, 18F-FDOPA or 68Ga-DOTATOC/DOTATATE scan) or scintigraphy (with 111In-pentetreotide imaging). * ECOG performance status of 2 or less. Exclusion Criteria: * Pregnancy * Medically unstable (eg. acute illness, unstable vital signs) * Unable to lie supine for the duration of imaging * Unable to provide written consent * Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm) * Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes. * Patients with baseline ALT or AST higher than 5× ULN or 250 U/L. * Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR \>1.2, or platelet count below the lower limit of normal (typically \<150 000/μL. * Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin.
References
Publications (0)
Data not yet available