To determine the correlation between neurocognitive function and the incidence of DTI abnormalities on MRI in irradiated glioma patients.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the correlation between neurocognitive function and DTI
abnormalities seen on MRI, expressed in fractional anisotropy (FA). Both will
be analyzed as a continuous variable. DTI parameters and cognition will also be
related to other MRI parameters.
Secondary outcome
n.a.
Background summary
Low grade gliomas occur in relatively young patients (between the ages of
30-50 years), have a good performance score, neurological function and
neurocognitive function when diagnosed. Patients with grade II or III glioma
and favorable prognostic features have a 10 year survival rate exceeding 50%.
Standard treatment consists of surgical debulking followed by postoperative
radiotherapy and chemotherapy.
Most patients develop cognitive dysfunction, which may greatly impact quality
of life for the patient but also for the next of kin. It is reasonable to
assume that cranial irradiation has a negative impact on neurocognitive
functioning. This may become apparent only after 5-10 years.
Diffusion tensor imaging (DTI) is an MRI-technique that can provide insight
into the microstructural integrity of cerebral white matter. It is more
sensitive to the detection of subtle white matter changes than conventional T1-
and T2 weighted imaging. Several studies exist in which MRI DTI was used to
study the effects of radiotherapy on white matter. These indicate the existence
of a dose-effect relationship as well as the existence of a relationship
between neurocognitive dysfunction and microstructural damage as revealed by
MRI DTI. However, these studies had very limited patient numbers and report
conflicting results.
Study objective
To determine the correlation between neurocognitive function and the incidence
of DTI abnormalities on MRI in irradiated glioma patients.
Study design
All patients that are in follow up receive an MRI-scan bi-annually. This scan
will be extended by 15 minutes to allow running the abovementioned DTI
sequence. Scans will be obtained on the 3 Tesla (Prisma) scanner. Measuring
neurocognitive function in patients is standard care and will be performed by
the treating neurologist or another health care provider. Afterwards, the
correlation between neurocognitive function and DTI abnormalities will be
investigated. Anatomical changes will be related to the irradiated volume.
Study burden and risks
Patients do not benefit from participation in this study. Standard diagnostic
and therapeutic procedures remain unchanges, regardless of any study outcomes.
Participants will not incur any additional costs if they participate. There
will be no financial re-imbursement. The extra burden for participating
patients is elongation of their next MRI examination by 15 minutes (55 instead
of 40).
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- WHO grade II or III glioma
- Radiotherapy received and still in follow-up, both in the UMCG
Exclusion criteria
- Younger than 18 years at the time of glioma diagnosis
- Disease progression requiring additional treatment since radiotherapy
- MRI contra-indicated
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 | NL67337.042.18 |