Metabolic MRI in brain cancer and epilepsy

Recruiting

Conditions: glioma
brain tumor
10029211
10011305

Registration Number: NL-OMON53308

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

All subjects: - Aged >18 years
- Ability to give informed consent
- Ability to follow test instructions
- Sufficient understanding of the Dutch or English language

Glioblastoma Patients in part 2a
- Patients who are newly diagnosed with a (suspected) glioblastoma IDH wild
type and with a relevant lesion (>1 cm3; prior to surgery) on conventional MRI
- Patients who will start treatment according to the Stupp regimen (for part 2a
only)

Epilepsy Patients in part 1
- Patients diagnosed with epilepsy with a relevant lesion detected by FDG PET

Epilepsy Patients in part 2b
- Patients diagnosed with epilepsy with or without a lesion on conventional MRI

Exclusion Criteria

- The presence of claustrophobia;
- MRI-specific exclusion criteria, such as metal implants.
- Refusal or inability to provide informed consent
- Pregnant or lactating
The presence of diabetes mellitus type 1 and 2;
The presence of a medical condition which influences brain metabolism

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1: Quantified rates of brain glucose metabolism; a scan is successfull if<br /><br>an SNR>5 for 2H-Glx is reached<br /><br><br /><br>Part 2a: Quantified levels of phospholipid metabolites and glucose metabolism<br /><br>in the tumor compared to those levels in healthy brain tissue from the same<br /><br>subject<br /><br><br /><br>Part 2b: Quantified levels of glucose metabolism in the epileptogenic cortex<br /><br>(determined by either a structural lesion, PET or neurophysiology) compared to<br /><br>healthy brain tissue from the same subject</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>Optimal dose of [6,6-2H2]-glucose<br /><br>Optimal timing between administration of [6,6-2H2]-glucose and static DMI<br /><br>Plasma glucose levels<br /><br>Deuterium enrichment of plasma water, lactate and glucose<br /><br><br /><br>Part 2a:<br /><br>Change in glucose metabolism and phospholipid levels in response to treatment<br /><br>pH levels of the tissue, assed by 31P MRSI<br /><br>redox status of the tissue, assed by 31P MRSI<br /><br>Change in tumor volume, measured on conventional imaging according to RECIST<br /><br>criteria<br /><br><br /><br>Part 2b:<br /><br>Glucose metabolism compared to FDG-PET metabolism<br /><br>Glucose metabolism in areas with invasive neurophysiological abnormalities</p><br>