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.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
Not applicable.
Background summary
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.
Study objective
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 burden and risks
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.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Patients with a low grade glioma >= 18 years old that are planned to undergo surgery and have given written informed consent
Exclusion criteria
- Patients with recent cerebral radiotherapy or surgery (<3 months)
- Age < 18 years
- General contra-indications for MRI which are non-MRI compatible ferromagnetic material, pregnancy (or possible pregnancy) and 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL64707.042.18 |
| Other | NTR volgt |
| OMON | NL-OMON24067 |