AimThe aim of this study is to determine if WMFA measured by DTI at 3T MRI in cancer survivors is a suitable biomarker in children between 8 -16 years of age for treatment induced neurotoxicity and related neurocognitive deficits.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Mental impairment disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
White matter fraction anisotropy as measured by MR.
Neurocognitive functioning of children including IQ as measured with
intelligence testing and questionaires.
Secondary outcome
The reason for refusal to participate will be registered in order to improve
the design of future ongoing studies concerning brain imaging and
neurocognitive outcome after childhood cancer.
Background summary
Background
Treatment-induced neurotoxicity by chemotherapy and radiotherapy is a major
cause of neurocognitive decline in childhood cancer survivors. Research to
investigate potential causes and neuroprotective treatment and intervention
methods is mandatory to try improve the neurocognitive outcome of these
children. New imaging techniques should be implemented to evaluate the benefit
of these strategies in terms of brain development or more specific decrease in
white matter damage.
Study objective
Aim
The aim of this study is to determine if WMFA measured by DTI at 3T MRI in
cancer survivors is a suitable biomarker in children between 8 -16 years of age
for treatment induced neurotoxicity and related neurocognitive deficits.
Study design
WFMA will be studied with the newly developed 3T MRI technique of 20 minutes
duration. The neurocognitive functioning of the both patients and control
persons will be judged by intelligence testing and speific questionaires for
parents and teacher.
Study burden and risks
The participation requires an MRI session of 20 minutes and an intelligence
test and questionaires taking about 3 hours. Cautious preparation and coaching
of the children will be performed surrounding the MRI and children will be
allowed to have their own MRI-picture of their brain. Both investigations
should be performed on two separate days in order to be fullfilled properly by
the children. The outcome of neurocognitive tests will be available to give
advice concerning strong and weak sides of the child in learning aspects. The
proposed control persons are most often concerning about class mates with
severe illness so we expect that potential candidates will be wiling to
particpate to be of help for their classmate as well as other children with
cancer. No risk are to be expected for the participants. Participation is
completely free and can be ended any moment the child wishes to do so.
PB 22660
1100 DD Amsterdam
Nederland
PB 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Age and sex matched control between 8-16 years selected from the classmates of the patient with an average cognitive performance
Exclusion criteria
1. Psychological contraindications for MR Imaging are claustrophobia and / or need for sedation to perform MRI successfully..
2. Physical contraindication for MR Imaging metallic implants or metallic orthodontic material.
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 | NL13926.018.06 |