Phase II Study of 68Ga-HA-DOTATATE PETCT Imaging for Patients with Known or Suspected Somatostatin Receptor Positive Tumors including Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the safety and diagnostic accuracy of 68Ga-HA-DOTATATE PETCT 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 MBqkg, with a minimum of 37 MBq and maximum of 250 MBq, followed by PETCT 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 PETCT 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.

68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors