None listed
Conditions
Brief summary
This research project aims to help improve detection methods for heart disease. The purpose of this research project is to investigate whether it is possible to prepare patients faster and whether it is possible to improve imaging of the heart for cardiac PET imaging. Usual practice is to have patients on a high fat, low carbohydrate diet from the evening beforehand and then to have them fasting for 4-6 hours immediately prior to the scan. The new method is called intravenous fat emulsion (trade name Intralipid), which should be able to be administered rapidly. This will be tested to see if it is an effective preparation for positron emission tomography using a sugar-based radionuclide as an alternative method of preparation.
Interventions
Both intervention and control groups will be healthy, screened with a medical history and examination Visit 1. They will be randomised into the experimental group, called "IV fat emulsion" group or the control group, the "no IV fat emulsion" group. Both groups will be allowed to continue their usual diet prior to scanning--a diet questionnaire will be taken on arrival for Visit 2. Oral glucose (15g) will be administered to both groups. In the experimental group, it will be administered 15 minute
Both intervention and control groups will be healthy, screened with a medical history and examination Visit 1. They will be randomised into the experimental group, called "IV fat emulsion" group or the control group, the "no IV fat emulsion" group. Both groups will be allowed to continue their usual diet prior to scanning--a diet questionnaire will be taken on arrival for Visit 2. Oral glucose (15g) will be administered to both groups. In the experimental group, it will be administered 15 minutes prior to IV intralipid administration (also 45 minutes prior to FDG administration). In the control group, it will be administered 45 minutes prior to FDG administration. The whole process will last 2-3 hours, involving the insertion of a cannula, the administration of the drug, the radionuclide and then the scan. The intervention group of 5 subjects randomised to the “IV fat emulsion” will receive IV fat emulsion 30 minutes prior to scanning. Intralipid is intravenous fat emulsion, comprising soya oil, egg lecithin and glycerol. The Intralipid group will receive the protocol used for local anaesthetic toxicity: Intralipid 20% 1.5mL/kg bolus dose followed by 30 minutes of 0.25mL/kg/min. Both groups will be imaged as per usual 18F-FDG cardiac PET protocol on Visit 2. After IV injection of 18F-FDG, subjects will be kept in a quiet room for 45-60 minutes. Plasma glucose measurements before injection will be taken in all volunteers. The acquisition will be limited to a single bed step encompassing the heart. Subjects will be instructed to breathe normally during image acquisition and will be iteratively reconstructed using attenuation correction. There will be a washout period of at least 2 hours before the intervention group receives the control group treatment ("no IV fat emulsion"). In brief, this will entail the same oral glucose load 45 minutes prior to administration of 18F-FDG and subsequent scanning with FDG cardiac PET as per usual protocol. There is a total of 2 scans administered to all participants, with the first on Visit 2 and the second on Visit 3.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Aged greater than or equal to 18 years Available to attend two visits for screening and imaging Able and willing to complete the informed consent process
Exclusion criteria
Previous diagnosis of Type I and Type II diabetes mellitus Previous diagnosis of ischaemic heart disease or ongoing symptoms of chest pain or previous cardiac surgery Allergies to lipid, glucose, soyabean, peanut or egg Pregnant or plans to become pregnant or breastfeeding Inability to lie flat (sleeping on greater than 2 pillows) or known claustrophobia Judged otherwise unfit by medical officer to participate in the trial
Outcome results
None listed