Primary objective is to study the association with preoperative 2-HG concentration, and progression free time in patients with a low grade glioma that are treated with vorasidenib.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the association between preoperative 2-HG levels (measured
with MR spectroscopy) an progression free time in patients with low grade
gliomas that are treated with Vorasidenib. Progression is defined according to
the RANO LGG criteria.
Secondary outcome
NA
Background summary
Lowgrade gliomas are brain tumors that are found in adolescents and young
adults. Up to now the only treatment was surgery with concomittand
chemoradiation or primary chemorafiation. All lowgrade gliomas have a IDH
genmutation, which leads to the production of 2-hydroxyglutararate (2-HG). 2-HG
can be measured with a specific MRI, MR spectroscopy. 2-HG is associated woth
disease progression and survival. Recently a study was published in which
patients that are treated with an inhibitor of 2-HG (vorasidenib) show longer
progression free time. Our hypothesis is that patients with higher 2-HG
concentrations will have better response to vorasidenib treatment, with longer
progression free time. In future studies these findings might aid in selecting
patients that will benefit from vorasidenib therapy.
Study objective
Primary objective is to study the association with preoperative 2-HG
concentration, and progression free time in patients with a low grade glioma
that are treated with vorasidenib.
Study design
Pilot study assessing the relationship between preoperative 2-HG levels and
progression free time in patients with lowgrade gliomas that are treated with
vorasidenib
Study burden and risks
Participating patients do not benefit grom this study. They will receive normal
diagnostic and therapeutic procedurs. There are no extra costs for
participants, and they do not receive compensation.The only discomfort is a one
time longer MRI time of 15 minutes.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Low grade glioma patients (WHO II), either suspected or histologically proven.
treated with vorasidenib
Signed informed consent.
Exclusion criteria
Age <18 years old.
Contra-indication for MRI.
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 | NL86417.042.24 |