No registrations found.
ID
Source
Health condition
2-HG
MRI
Spectroscopy
Low grade glioma
IDH
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the correlation between the presence of the IDH mutation and a 2-HG peak on MR spectroscopy (binary variables). Also primary endpoint is the correlation between the concentration of 2-HG on in vivo MR spectroscopy and ex vivo in the tissue, uitgedrukt in mmol/mg (continue variabelen).
Secondary outcome
not applicable
Background summary
Background of the study: Low grade gliomas are brain tumors that occurs mainly in young adults. The mean survival is about 10 years. The tumor might be difficult to resect if located near an important brain area. Treatment is best done using radiotherapy and chemotherapy in such cases. However, the diagnosis should be established with certainty with a brain biopsy. However, a biopsy induces the risk of brain damage. Unfortunately, a brain biopsy is the only way to establish the diagnosis with certainty currently.
An alternative seems possible. Low grade gliomas have a IDH gene mutation. This mutation results in the production of 2-hydroxyglutarate (2-HG). 2-HG seems to be measurable on a specific MRI sequence, MR spectroscopy.
The current pilot study will investigate if this IDH gene mutation indeed result in the presence of 2-HG on MRI. We also validate if the concentration measured on MRI correlate with the concentration measured in the tissue.
If indeed positive, we are able to set-up an follow-up study (not part of the current protocol) to see if the 2-HG MR scan could replace a brain biopsy in patient with a low grade gliomas.
Objective of the study: Primary goal is to investigate if the 2-HG peak on in vivo MR spectroscopy correlates with the ex vivo IDH mutation and 2-HG concentration in patients with a low grade gliomas.
Study design: A pilot study to validate 2-HG spectroscopy in patients with a low grade glioma.
Study population: Patients with a low grade glioma ≥ 18 years old that a planned to undergo surgery (N=10).
Primary study parameters/outcome of the study: Primary endpoint is firstly the correlation between the presence of the IDH mutation and the presence of the 2-HG peak on MR spectroscopy (binary variables). Also primary endpoint is the correlation between the concentration of 2-HG on in vivo MR spectroscopy and ex vivo in the tissue in mmol/mg (continue variables).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): Participants will not have and advantages from participation in the research. The standard clinical diagnostic and therapeutic procedures will not change. Participants will have no additional costs and will not receive any financial compensation. The discomfort is that they will have to lay down 15 minutes longer in the already planned MRI scan. The MRI will last 55 minutes instead of 40 minutes.
Study objective
We expect that patients with a IDH mutation demonstrate an increase in 2-HG on MR spectroscopy. We also expect a positive correlation between in vivo 2-HG on MR spectroscopy and ex vivo concentration in tissue.
Study design
pre-operative MR Spectroscopy. 2-HG tissue concentration measurement post-operative ex-vivo.
Intervention
MR spectroscopy for 2-HG.
A. Hoorn, van der
PO Box 30 001
Groningen 9700 RB
The Netherlands
+31503616161
a.van.der.hoorn@umcg.nl
A. Hoorn, van der
PO Box 30 001
Groningen 9700 RB
The Netherlands
+31503616161
a.van.der.hoorn@umcg.nl
Inclusion criteria
Patients with a low grade glioma ≥ 18 years that are planned to undergo surgery
Exclusion criteria
- Patients with recent cerebral radiotherapy or operation (<3 months).
- Age <18 years.
- General contra-indications for MRI (non compatible material , pregnancy or claustrophobia)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6798 |
NTR-old | NTR6984 |
CCMO | NL64707.042.18 |
OMON | NL-OMON46642 |