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Clinical Trials/NCT03771625
NCT03771625UnknownNot Applicable

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

Beijing Neurosurgical Institute1 site in 1 country30 target enrollmentStarted: June 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Changes of white matter fibers measured by DTI after treatments.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
3 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Changes of white matter fibers measured by DTI after treatments.

Time Frame: The DTI scans are performed along with the fMRI scans.

The white matter fibers damaged by tumor are evaluated by FA and MD value.

Changes of brain networks measured by BOLD-fMRI after treatments.

Time Frame: 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.

The brain networks during treatments are compared by functional connectivity.

Secondary Outcomes

  • Changes of muscle strength after treatments.(The muscle strength evaluation are performed at the same day before the fMRI scans.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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