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

Official Title

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

Summary:

Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumours. 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).

Trial Description

Primary Outcome:

• Efficacy - sensitivity
• Efficacy - specificity

Secondary Outcome:

• Safety - adverse events - immediate
• Safety - adverse events - post-scan
• Safety - adverse events - delayed

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 tumours. 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.

View this trial on ClinicalTrials.gov