Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000279426
Ethics application status
Approved
Date submitted
24/02/2016
Date registered
2/03/2016
Date last updated
19/11/2021
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of intravenous fat emulsion an alternative method of preparing patients for positron emission tomography (PET) imaging of the heart
Scientific title
Does intravenous fat emulsion adequately suppress 18-fludeoxyglucose uptake in myocardium for glucose-loaded healthy volunteers undergoing cardiac positron emission tomography: a randomised crossover trial
Secondary ID [1] 288623 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal cardiac function 297777 0
Heart disease 297791 0
Condition category
Condition code
Cardiovascular 297962 297962 0 0
Normal development and function of the cardiovascular system
Cardiovascular 297975 297975 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294026 0
Diagnosis / Prognosis
Comparator / control treatment
Both intervention and control groups will be healthy, screened with a medical history and examination on 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, administration the radionuclide and then the scan.

The control group of 5 subjects randomised to the “IV fat emulsion” will wait for 45 minutes before FDG is administered. 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 control group receives the intervention group treatment ("IV fat emulsion"). In brief, this will entail the same oral glucose load 15 minutes prior to administration of IV intralipid (or 45 minutes prior to of 18F-FDG administration) 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.
Control group
Active

Outcomes
Primary outcome [1] 297480 0
Qualitative (visual categoric uptake scale) comparative assessments of 18F-FDG myocardial uptake in both arms
Timepoint [1] 297480 0
Visit 2 and Visit 3 (likely Day 0 to Day 7)
On each of these days:
0 minutes - FDG is injected and patient is placed in quiet, dark room
60 minutes - PET scan is performed and measurements are taken at that time
Primary outcome [2] 297529 0
Quantitative (minimum standardised uptake value and maximum standardised uptake value) comparative assessments of 18F-FDG myocardial uptake in both arms,
Timepoint [2] 297529 0
Visit 2 and Visit 3 (likely Day 0 to Day 7)
On each of these days:
0 minutes - FDG is injected and patient is placed in quiet, dark room
60 minutes - PET scan is performed and measurements are taken at that time
Secondary outcome [1] 321166 0
To assess for any immediate medical adverse effects post-preparation with IV fat emulsion in PET scans.

The known risks related to IV fat emulsion are low. Most side effects are not serious, such as raised body temperature, shivering, chills, nausea and vomiting (less than 3%). Occasionally, serious medical complications develop including severe allergic reaction or blood disorders can develop (1 per 1,000,000).

After the procedure, the participant will be monitored for 30 minutes for complications such as any persisting symptoms of shivering, chills, abdominal pain, bleeding, anaphylaxis. This will be performed by asking the patient and performing vital signs including blood pressure, heart rate, respiratory rate, and capillary oxygen saturation and temperature. If the patient has any concerns after this, they will be referred to their General Practitioner or will be able to contact Principal Investigator Doctor Michael Li in hours.
Timepoint [1] 321166 0
Visit 2 or Visit 3 (Day 0 or Day 7) - depending on when fat emulsion is received.
0 minutes - IV fat emulsion administration
30 minutes - FDG administration
90 minutes - PET scan and images are taken
120 minutes - history from participant of adverse events and vital signs taken
After 120 minutes - contact Principal Investigator for any events

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 10 patients (10 matched pair measurements) is sufficient to detect an effect size of 1 with power 0.8, which is considered to be a large effect size, with a 2-sided type I error rate of 0.05. (The effect size is equal to the hypothesised difference between group means divided between the within group standard deviation).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
7/01/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
2/06/2021
Date of last data collection
Anticipated
Actual
28/06/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10271 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 21938 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 292978 0
Hospital
Name [1] 292978 0
Australian & New Zealand College of Anaesthetists
Country [1] 292978 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
146 Studley Rd
Heidelberg
VIC 3084
Country
Australia
Secondary sponsor category [1] 291750 0
None
Name [1] 291750 0
Address [1] 291750 0
Country [1] 291750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299829 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 299829 0
Ethics committee country [1] 299829 0
Australia
Date submitted for ethics approval [1] 299829 0
04/05/2018
Approval date [1] 299829 0
24/09/2018
Ethics approval number [1] 299829 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63894 0
Dr Michael Li
Address 63894 0
Peter MacCallum Cancer Centre
Department of Anaesthesia and Perioperative Medicine
Division of Cancer Surgery
Locked Bag 1 A’Beckett St
VIC 8006
Country 63894 0
Australia
Phone 63894 0
+613 9656 1111
Fax 63894 0
Email 63894 0
[email protected]
Contact person for public queries
Name 63895 0
Michael Li
Address 63895 0
Peter MacCallum Cancer Centre
Department of Anaesthesia and Perioperative Medicine
Division of Cancer Surgery
Locked Bag 1 A’Beckett St
VIC 8006
Country 63895 0
Australia
Phone 63895 0
+613 9656 1111
Fax 63895 0
Email 63895 0
[email protected]
Contact person for scientific queries
Name 63896 0
Michael Li
Address 63896 0
Peter MacCallum Cancer Centre
Department of Anaesthesia and Perioperative Medicine
Division of Cancer Surgery
Locked Bag 1 A’Beckett St
VIC 8006
Country 63896 0
Australia
Phone 63896 0
+613 9656 1111
Fax 63896 0
Email 63896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.