GlucoCEST MRI of the brain in healthy volunteers and patients with brain tumours

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

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