Clinical trial · Interventional
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
- 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)
Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy. This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-HA-DOTATATE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-HA-DOTATATE PET/CT scan
- description
- 2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
- interventionNames
- Drug: 68Ga-HA-DOTATATE
Primary outcomes (2)
- measure
- Efficacy - sensitivity
- timeFrame
- 1 year post-scan
- description
- Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
- measure
- Efficacy - specificity
- timeFrame
- 1 year post-scan
- description
- Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma * A standard clinical CT or MRI is obtained within 6 months of enrollment * Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker) Exclusion Criteria: * Weight \> 225 kg (weight limit of the PET/CT scanner) * Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging * Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation * Previous allergic reaction to DOTATATE or somatostatin analogues * Lack of intravenous access
References
Publications (0)
Data not yet available