Actively Recruiting
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Led by University of Alberta · Updated on 2026-05-11
600
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and diagnostic accuracy of 68Ga-HA-DOTATATE PET/CT imaging for patients with known or suspected somatostatin receptor positive tumors, such as gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others. This phase II, single-center, non-randomized study aims to assess this new tracer produced at the Edmonton Radiopharmaceutical Centre, comparing it to standard CT or MRI imaging over a one-year follow-up period. Participants will receive a single intravenous dose of 68Ga-HA-DOTATATE at 2.64 MBq/kg, with a minimum of 37 MBq and maximum of 250 MBq, followed by PET/CT scanning. Up to 600 scans will be performed over six years, including both adult and pediatric patients. Some patients may undergo multiple scans during the study. Safety will be monitored immediately after injection, post-scan, and at 10 days, while efficacy will be evaluated by comparing imaging results to clinical follow-up. During the study, participants will undergo PET/CT scans and standard clinical CT or MRI within six months before enrollment. Adverse events will be tracked closely in the Nuclear Medicine department, and diagnostic accuracy will be assessed through sensitivity and specificity measures at one year post-scan. The study duration allows for comprehensive safety and efficacy evaluations, helping to inform clinical care for patients with these tumors.
CONDITIONS
Brief Title
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with known or suspected somatostatin receptor positive tumors including gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others
- Standard clinical CT or MRI obtained within 6 months of enrollment
- Ability to provide written informed consent or have a legal medical decision maker consent
You will not qualify if you...
- Weight greater than 225 kg (PET/CT scanner limit)
- Inability to undergo scanning such as extreme claustrophobia or inability to lie still
- Any medical condition or serious illness that may interfere with study or interpretation
- Previous allergic reaction to DOTATATE or somatostatin analogues
- Lack of intravenous access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intravenous injection of 68Ga-HA-DOTATATE tracer followed by a PET/CT scan to evaluate somatostatin receptor positive tumors.
1 visit (in-person)
Duration - 1 year
Participants are monitored for safety and efficacy, including assessment of adverse events immediately and up to 10 days after the scan, as well as clinical evaluation for up to 1 year post-scan.
Safety assessments immediately after tracer injection and scan, and follow-up at 10 days; clinical evaluations over 1 year
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
Research Team
J
Jonathan Abele, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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