A Phase 2 interventional study of 68Ga-HA-DOTATATE in Neuroendocrine Tumors, sponsored by University of Alberta. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Alberta · Phase 2, Interventional, and Diagnostic
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).
A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors.
Up to 600 scans will be included over 6 years. All patient ages (pediatric and adult) will be included. Individual patients may have more than one scan during the study period.
Safety evaluation will consist of an adverse event assessment whil in the Nuclear Medicine department at the University of Alberta Hospital. Efficacy evaluation will consist of a comparison to CT and/or MRI accuracy based on 1 year follow-up clinical evaluation.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's planned enrollment of 600 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
Drug: 68Ga-HA-DOTATATE
Tracer injection
Efficacy - sensitivity
Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Time frame: 1 year post-scan
Efficacy - specificity
Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Time frame: 1 year post-scan
Safety - adverse events - immediate
Assessment of adverse events immediately after tracer injection
Time frame: Immediately (within 15 minutes) after tracer injection
Safety - adverse events - post-scan
Assessment of adverse events immediately after PET/CT scan
Time frame: Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection
Safety - adverse events - delayed
Self-reporting of possible adverse events after leaving the PET department
Time frame: 10 days after tracer injection
Plan to share: No
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University of Alberta