Clinical trial · Observational
DOTATOC PET/CT for Imaging NET Patients
Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC 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 68Gallium(68Ga)-DOTATOC positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the safety and sensitivity of 68Ga-DOTATOC PET/CT at detecting NETs and other tumors with over-expression of somatostatin receptors.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid | Neuroendocrine Tumor | ALIAS | 0.90 |
| Ganglioneuroma | Ganglioneuroma | ONTOLOGY_EXACT | 0.98 |
| Gastrinoma | Gastrin-Producing Neuroendocrine Tumor | ALIAS | 0.90 |
| Glucagonoma | Pancreatic Glucagonoma | ALIAS | 0.90 |
| Insulinoma | Pancreatic Insulinoma | ALIAS | 0.90 |
| Medullary Carcinoma | — | UNRESOLVED | — |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroblastoma | Neuroblastoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
| 68Ga-DOTATOC 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-DOTATOC and the other using 18F-FDG. The 68Ga-DOTATOC radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.
- interventionNames
- Diagnostic Test: 68Ga-DOTATOC PET/CT
- Diagnostic Test: 18F-FDG PET/CT
Primary outcomes (1)
- measure
- Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors.
- timeFrame
- 3 years
- description
- Determination of sensitivity of both exams when compared with pathology reports (if available) and compared with routine imaging (CT, MRI, Octreoscan™, US) if available and will be determined by confidence intervals using an exact binominal distribution by comparing the 68Ga-DOTATOC PET/CT with 18F-FDG and conventional imaging (if available). The gold standard for the detection of lesions will be established through a combination of: 1) pathology; 2) unequivocal correlative imaging results as assessed independently by 2 physicians; 3) disease progression of specific findings upon follow-up, up to three years from baseline examination; 4) a clearly unequivocal plurimetastatic pattern confirmed by any imaging modality at any of the involved sites; 5) response of lesions on subsequent imaging following therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: All subjects: * World health organization performance status 0-2 * Able to provide written informed consent/assent (or consent by guardian for subjects \<19 years) * Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 30 minutes and tolerating intravenous cannulation for injection. Patients must require imaging for either staging or re-staging of: * Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma, VIPoma, etc.), functioning and non-functioning * Sympathoadrenal system tumors (phaeochromocytoma, paraganglioma, neuroblastoma, ganglioneuroma) * Medullary thyroid carcinoma * Pituitary adenoma * Medulloblastoma * Merkel cell carcinoma * Small-cell lung cancer (mainly primary tumors) * Meningioma * Or any other NET / with potential for overexpression of SSTR Exclusion Criteria: * Pregnancy * Patients who are medically unstable ex: acute cardiac or respiratory distress, hypotensive * Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70cm).
References
Publications (0)
Data not yet available