The primary objective is to increase our understanding of the glucoCEST signal by comparing glucoCEST MRI to [18F]FDG-PET in patients with brain tumours on the hybrid PET/MRI scanner of the Erasmus MC. The secondary objective is to explore the…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
GlucoCEST signal of pre-, during and post-glucose bolus injection values,
standardized uptake value (SUV), signal-to-noise-ratio (SNR),
contrast-to-noise-ratio (CNR), tumour volume, tumour perfusion
Secondary outcome
N/A
Background summary
The incidence of brain tumours is increasing. Several advanced treatments for
brain tumours have resulted in improved survival, but also in an increase of
treatment related effects. These may occur early (often labelled as
pseudoprogression) or late (radionecrosis) and both cannot readily be
distinguished from true tumour progression with magnetic resonance imaging
(MRI) techniques currently available in clinical practice. Therefore, new
imaging techniques are explored for better diagnosis and response assessment in
patients with brain tumours but so far with limited success.
Glucose uptake and metabolism is often increased in tumours compared to normal
tissue, known as the Warburg effect. This Warburg effect has been exploited in
2-[18F]-fluoro-2-deoxy-D-glucose ([18F]FDG)-positron emission tomography (PET)
imaging. A recent MRI technique called glucose Chemical Exchange Saturation
Transfer (glucoCEST), assesses naturally available glucose (i.e. dextrose or
D-glucose) instead of FDG; therefore it has the potential to more accurately
assess glucose metabolism. Previous studies have compared glucoCEST MRI to
[18F]-FDG-PET in murine models on scanners with high field strength (7T or
higher), showing a potential correlation between glucoCEST signal and
[18F]-FDG-PET signal. In this study, we aim to compare glucoCEST MRI with
[18F]FDG-PET on the PET/MRI scanner (3T) in patients with brain tumours, to
increase our understanding of the component of the glucoCEST signal derived
from glucose uptake. In addition, we aim to explore the clinical potential of
glucoCEST MRI in response assessment.
Study objective
The primary objective is to increase our understanding of the glucoCEST signal
by comparing glucoCEST MRI to [18F]FDG-PET in patients with brain tumours on
the hybrid PET/MRI scanner of the Erasmus MC. The secondary objective is to
explore the clinical potential of glucoCEST MRI as routine evaluation tool for
response assessment, by comparing signal differences of glucoCEST MRI to
clinically used response parameters pre- and post anti-cancer treatment. The
third objective is to explore which other components constitute the glucoCEST
signal.
Study design
This is a single centre, non-randomised, prospective and explorative imaging
study.
Study burden and risks
GlucoCEST MRI (as described in our previous METC-protocol, MEC-2020-0752)
requires the insertion of two cannulae (venflons), a 3.2 minute bolus D-glucose
infusion (50mL of 50% solution, through one of the two cannulae), venous blood
draws (max. of 16mL, drawn from the other cannula), and MRI. Glucose infusion
will induce short term hyperglycaemia, which may cause - generally minor -
adverse effects: throbbing headache and a warm feeling to head and groin
(feeling of miction), which last for only tens of seconds during infusion; and
seldom, thrombophlebitis, which then develops within a week after placement of
the cannulae.
[18F]FDG-PET requires intravenous administration of [18F]-FDG and imaging using
PET, according to local protocol. An average patient of 75kg will receive 185
MBq, with an effective dose estimated at 3.6 mSv per injection. It is optional
for patients to undergo dynamic PET scanning, which requires additional venous
blood draws (up to 6 samples, a total of 60mL). In patients with a PET-scan
scheduled for clinical purposes, the study scan will be added to that clinical
scan; then, no additional dose of [18F]FDG is required for the study. Patients
without a clinical PET-scan will only receive the study scan, with a single
dose of [18F]FDG. However, if the treating physician believes that an
additional PET-MRI scan (e.g. of thorax and abdomen) will be of clinical value
for the patient, such a scan will be combined with the study scan (thereby
using the same single dose of [18F-FDG]). In addition, this can potentially
replace a clinical CT-scan of thorax and abdomen, thereby reducing radiation
burden from CT.
The total time of glucoCEST MRI and [18F]FDG-PET imaging within the same,
single scanning session on the PET-MRI scanner, will be no longer than 90
minutes. The participants are asked to lay in the scanner during this period,
which may cause discomfort for the participants.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years
• Primary intra-axial brain tumour of any type or secondary brain tumour (brain
metastases) of any solid tumour
• Signed and dated written informed consent form prior to any study-specific
procedures
• WHO performance status of 0 or 1
Exclusion criteria
• Glucose- and/or FDG-infusion related exclusion criteria:
o Uncontrolled Diabetes Mellitus type 1 or 2 (requiring fast-acting insulin)
o Uncontrolled tonic-clonic seizures (>1 per month despite anti-epileptic
treatment)
• Not being able to undergo contrast enhanced MR scans or [18F]FDG-PET exam (in
line with local protocol13):
o Pacemaker, mechanic heart valve, blood vessel prosthetic, stent or coil
incompatible with MR scanning
o Metal in eyes (splinters, from surgery), ears (hearing aid) or on the body
where it cannot be removed (e.g. insulin pump, piercings)
o Dental prosthesis with magnetic system
o Breastfeeding
o Pregnancy
o Claustrophobia
o Known anaphylactic reaction to [18F]FDG or gadolinium-based contrast agents
• Severe blood iron deficiency (with haemoglobin concentration <6.0mmol/L)
• History of severe renal disease/renal transplant, or an eGFR (MDRD)
<30mL/min/1,73m2
• Has any medication that decreases the chances of obtaining reliable data and
achieving the study objectives
• History of somatic or psychiatric disease/condition that may interfere with
the objectives and assessments of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81367.078.22 |