68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
- Registration Number
- NCT04888481
- Lead Sponsor
- University of Alberta
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-HA-DOTATATE PET/CT scan 68Ga-HA-DOTATATE 2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
- Primary Outcome Measures
Name Time Method Efficacy - sensitivity 1 year post-scan Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Efficacy - specificity 1 year post-scan Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
- Secondary Outcome Measures
Name Time Method Safety - adverse events - delayed 10 days after tracer injection Self-reporting of possible adverse events after leaving the PET department
Safety - adverse events - immediate Immediately (within 15 minutes) after tracer injection Assessment of adverse events immediately after tracer injection
Safety - adverse events - post-scan Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection Assessment of adverse events immediately after PET/CT scan
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada