To develop a protocol for glucoCEST MRI for brain using the MRI of the recently installed fully integrated PET/MRI apparatus at Erasmus MC.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To optimize a glucoCEST protocol for MRI of the brain in healthy volunteers and
patients with brain tumours.
Secondary outcome
Test-retest reliability will be determined.
Background summary
Since primary brain tumours and brain metastases have an increased glucose
metabolism, assessment of glucose uptake and metabolism is promising for
diagnosis and response evaluation of these tumours. In clinical practice,
positron emission tomography (PET) using [18F]-labeled fluorodeoxyglucose PET
([18F]-FDG) is extensively used for detection and staging of cancer, but this
technique cannot be applied for intracerebral malignancies because of high
physiological [18F]-FDG uptake in normal brain. Using glucose as a natural
contrast agent, glucoCEST is a promising new in vivo magnetic resonance imaging
(MRI) technique for assessment and quantification of glucose uptake in
malignant brain tumours.
Study objective
To develop a protocol for glucoCEST MRI for brain using the MRI of the recently
installed fully integrated PET/MRI apparatus at Erasmus MC.
Study design
Single center explorative diagnostic study.
Study burden and risks
Participation in this study requires bolus glucose infusion, blood draws and
imaging.
Glucose infusion will induce short term hyperglycemia, which may cause -
generally minor - adverse effects: throbbing headache, warm feeling to head
and groin (feeling of miction), which lasts for only tens of seconds, and
thrombophlebitis. These are particularly seen with infusion times of 1 or 2
minutes. In the current protocol, the infusion time of glucose will be 3 to 4
minutes. Two intravenous cannulas will be inserted, one in each arm, one for
blood draws and one for glucose infusion.
At baseline, 14,5 mL of blood will be drawn. During scanning, approximately
15,4 mL of blood will be drawn. The risk of drawing this limited amount of
blood is minimal. Total scan time will be maximally 90 minutes. Subjects will
be exposed to noise from the MR apparatus. Although the PET/MRI apparatus will
be used, PET will not be applied. As only MRI is applied, there is no radiation
burden. During the study accidental findings can occur, that can have clinical
consequences (MRI-scan/abnormal blood values).
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteer:
- Disease currently not requiring prescription medication
- Baseline venous glucose level below 11.0 mmol/L
- Age >= 18 years
- Signed and dated written informed consent prior to any study-specific
procedures
Patient:
- WHO performance status of 0 or 1
- Baseline venous glucose level below 11.0 mmol/L
- Age >= 18 years
- Signed and dated written informed consent prior to any study-specific
procedures
Exclusion criteria
Healthy volunteer:
- Glucose infusion related exclusion criteria:
* Diabetes Mellitus type 1 or 2 (self-reported or 2 measurements on separate
days of a non-fasting glucose level >11 mmol/L or fasting glucose level >=7,0
mmol/L)
* Sickle cell disease or blood iron deficiency (haemoglobin concentration <9.6
g/dL = 6.0 mmol/L)
- Contra-indications for MRI exam (see the list below)
- History of seizures
- History of severe hepatic disease/liver transplant
- History of renal disease, or abnormal baseline blood sample of creatinine
(31-68 µmol/L), urea (3.3-5.6 mmol/L) or eGFR (<60 mL/min)
- History of somatic or psychiatric disease/condition that may interfere with
the objectives and assessments of the study
Patient:
- Glucose infusion related criteria:
* Diabetes Mellitus type 1 or 2 (self-reported or 2 measurements on separate
days of a non-fasting glucose level >=11.0 mmol/L or a fasting glucose level
>=7.0 mmol/L)
* Sickle cell disease or blood iron deficiency, with haemoglobin concentration
<9.6 g/dL = 6.0 mmol/L)
* Has any medication that decreases the chances of obtaining reliable data and
achieving the study objectives
- Contra-indications for MRI exam (see the list below)
- History of seizures
- History of severe hepatic disease/liver transplant
- History of severe renal disease/renal transplant, or abnormal baseline blood
sample of eGFR (<30 mL/min)
- History of somatic or psychiatric disease/condition that may interfere with
the objectives and assessments of the study
General contra-indications for MRI exam (all subjects):
* Surgery in the last 6 weeks
* Pacemaker, mechanic heart valve, blood vessel prosthetic, stent or coil
* Metal in eyes (splinters, from surgery) or ears (hearing aid) or on the body
where it cannot be removed (insulin pump, piercings etc.)
* Dental prosthesis with magnetic system
* Pregnancy or breastfeeding
* Claustrophobia
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 | NL73988.078.20 |