68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-HA-DOTATATE.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Tumors. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 68Ga-HA-DOTATATE
Tracer injection
Primary outcome measures
- Efficacy - sensitivity [Time frame: 1 year post-scan]
- Efficacy - specificity [Time frame: 1 year post-scan]
Secondary outcome measures (3)
- Safety - adverse events - immediate [Time frame: Immediately (within 15 minutes) after tracer injection]
- Safety - adverse events - post-scan [Time frame: Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection]
- Safety - adverse events - delayed [Time frame: 10 days after tracer injection]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT04888481 · CC-19-0369