Clinical trial NCT03771625: Evaluating Structural and Functional Changes of Brain by fMRI and DTI in Patients With Intracranial Germ Cell Tumors
Official title: Evaluating Changes of Brain Networks and White Matter Fibers by fMRI and DTI After Treatments in Patients With Germ Cell Tumors in the Basal Ganglia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Germ Cell Tumor
Keywords: fMRI
DTI
Intracranial Germ cell tumor
Basal ganglia
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracranial germ cell tumor located at the basal ganglia.

Brief summary: BOLD-fMRI and DTI scans are performed to patients with germ cell tumors in the basal ganglia before and after treatments. The changes of the MRI and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

Detailed description: Primary intracranial germ cell tumors are a specific entity of brain tumors with a variety of histological types and different degrees of malignancy. Intracranial GCTs make up 11.2% - 15.3% of primary intracranial tumors in Asian children compared with 3.6% in the US. And tumors located at the basal ganglia is much rarer.

The investigators realize that most of patients with tumors at this location are involved with motor disfunction. And after treatments, some patients get relieved dramatically, but some others failed to get similar outcomes. To better understand the mechanism causing this difference of treatment outcomes, the investigators perform BOLD-fMRI and DTI scans to patients with germ cell tumors in the basal ganglia before and after treatments. The changes of the fMRI and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

Eligibility criteria: Inclusion Criteria:

1. age ≥3 years;
2. no history of brain radiotherapy;
3. no other known cause of movement and cognitive impairment;
4. no contraindications to the magnetic resonance imaging (MRI) scan;

Exclusion Criteria:

1. patients can not tolerate MR scan;
2. head motion is greater than 3 mm during functional MRI scanning.

Primary outcomes:
measure: Changes of brain networks measured by BOLD-fMRI after treatments.
timeFrame: The fMRI scans are performed: (1) before treatments in one week, (2) before radiotherapy in one week, (3) after radiotherapy in one week, (4) one year after radiotherapy.
measure: Changes of white matter fibers measured by DTI after treatments.
timeFrame: The DTI scans are performed along with the fMRI scans.
Secondary outcomes:
measure: Changes of muscle strength after treatments.
timeFrame: The muscle strength evaluation are performed at the same day before the fMRI scans.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References:
citation: Liang SY, Yang TF, Chen YW, Liang ML, Chen HH, Chang KP, Shan IK, Chen YS, Wong TT. Neuropsychological functions and quality of life in survived patients with intracranial germ cell tumors after treatment. Neuro Oncol. 2013 Nov;15(11):1543-51. doi: 10.1093/neuonc/not127. Epub 2013 Oct 6.