this study aims to evaluate the clinical value of ASL in the clinical MRI protocol of children with a brain tumor. To serve the sample size calculation, its primary objective is to assess whether there is a correlation between perfusion of (parts of…
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
baseline cerebral blood flow, tumor World Health Organization malignancy grade
diagnosed by histology.
Secondary outcome
cerebral blood flow at follow-up; results of the clinical scans at baseline and
follow-up
Background summary
To optimize diagnosis of children with brain tumors, it is important to
estimate the malignancy of the tumor in the best possible way. As aggressive
tumors form new vessels to sustain their growth, perfusion of the tumor can
serve as an estimate of malignancy. Arterial spin labeling (ASL) is a new
non-invasive perfusion MRI technique which, as compared to former perfusion
imaging techniques, provides direct quantification without the need for
contrast administration. Furthermore, it is less hampered by blood-brain
barrier breakdown. The value of ASL has been extensively studied in adults with
brain tumors.
Study objective
this study aims to evaluate the clinical value of ASL in the clinical MRI
protocol of children with a brain tumor. To serve the sample size calculation,
its primary objective is to assess whether there is a correlation between
perfusion of (parts of) the tumor and its histological grading. Secondary
objectives investigate whether 2) ASL exhibits specific pitfalls in children
with brain tumors; 3) ASL differentiates between tumor recurrence and radiation
necrosis; 4) tumor compression, chemotherapy or radiation therapy change the
perfusion of the surrounding brain tissue; 5) changes in tumor perfusion
shortly after start of therapy are predictive for the therapeutic effect; 6)
perfusion can functionally serve neurosurgery.
Study design
an observational single center cohort study with maximal duration of four
years. Investigations will be both cross-sectional and longitudinal. The
ASL-scan will be added to the routine MRI brain tumor protocol for every
instance that the subject will undergo a MRI scan, such as for diagnostic
work-up, before and after treatment and at follow-up.
Study burden and risks
ASL will be added to the clinical cranial MRI protocol. This implies that each
clinical MRI examination is extended with 10 minutes. No separate MRI
examination is performed. ASL is a non-invasive imaging modality, similar to
the routine clinical MRI-scans. The 10 extra minutes do not differ from the
clinical MRI-scans. No additional contrast administration is required. MRI
studies in children were previously approved by the medical ethics review board
of the Academic Medical Center. Extensive coaching and preparation of the
children to prevent anxiety is part of the clinical MRI scanning procedure.
Every possible step is undertaken to make sure the burden associated with the
MRI scans is kept to a minimum. The risks associated with the extra MRI scan
are negligible, and the added burden is considered minimal. Unanticipated
claustrophobia will have been discovered before start of the added ASL-scan
(20th minute of acquisition).
Meibergdreef 9
1105 AZ Amsterdam, NL
NL
Meibergdreef 9
1105 AZ Amsterdam, NL
NL
Listed location countries
Age
Inclusion criteria
- 0 to 18 years of age
- appointed to undergo a MRI-scan (all cranial MRI-scans during follow-up will be included)
- suspected, diagnosed or (previously) treated brain tumor (i.e. cranial central nervous system (CNS)-tumor)
Exclusion criteria
- patients who do not meet the specific inclusion criteria;
- contraindications for MRI, such as claustrophobia or the presence of metal in the body;
- inability of parents/legal guardians or patients themselves, if older than 12 years of age, to provide informed consent;
- refusal by the child of any age before or during the imaging procedure
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 | NL37713.018.11 |