A standard imaging test used to look for disease in the body is a positron emission tomography (PET) scan. These scans use a small amount of a radioactive substance, called a radiotracer. The most commonly used radiotracer is FDG, which shows us how the body uses glucose (a type of sugar). However, because the brain and heart naturally use a lot of glucose, the images can have background 'noise' making it harder for doctors to see signs of disease in these organs. NeuCaVis is a new type of radiotracer that is being investigated in this study. It works by showing us how the body uses different kind of sugar, fructose. Outside of the digestive system, fructose is not normally used by healthy tissues. It is only used for energy when inflammation is present. The purpose of this study is to evaluate the safety, tolerability and how NeuCaVis is distributed in normal tissue throughout the body. This is the first time this is being tested in people. Participants will undergo a series of PET/CT scans following an intravenous injection of NeuCaVis. The first will be 90 minutes, then a 25 minute break, followed by a 10 minute scan, a 105 minute break, then a final 10 minute scan. A follow up phone call will occur 1-3 days later. In the optional sub-set study, participants will return to the clinic approximately 1-2 weeks after the first scan. The additional PET scan is already used in medical care and involves administration of an approved PET radiotracer, \[18F\]FDG. Researchers would compare this scan to the study PET scan with NeuCaVis. For this standard of care scan, it would be necessary to fast (not to eat or drink anything, except water) for at least 12 hours prior to receiving the FDG radiotracer injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
PET radiotracer
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
RECRUITINGIncidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Categorized by type, severity and relationship
Time frame: Adverse events are collected on each day participants undergo PET scanning (Day 1 and optional sub-study Day 8-15) and at safety follow-up visits two days post scanning.
Radiotracer uptake measured in major organs
Measured by SUV and mean uptake time for radiotracer. Visual analysis for any non-physiological radiotracer uptake.
Time frame: Day 1
Whole blood and plasma radioactivity counts
Measured at 0.5 to 250 min post-injection. Time-activity curves (TACs) for major organs.
Time frame: Day 1
Overall visual grading score
Measured by present or not present
Time frame: Day 1
Qualitative scoring scale
Measured by none (0), minimal (1), mild (2), moderate (3), severe (4) for LV myocardium
Time frame: Day 1
Image quality
Measured by non-diagnostic (0), poor (1), fair (2), good (3), excellent (4)
Time frame: Day 1
Cardiac and brain uptake
Measured by none (0), minimal (1), mild (2), moderate (3), extreme (4)
Time frame: Day 1
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