Evaluating Structural and Functional Changes of Brain by fMRI and DTI in Patients With Intracranial Germ Cell Tumors

• Conditions: Intracranial Germ Cell Tumor
• Interventions: Radiation: radiotherapy

• Registration Number: NCT03771625
• Lead Sponsor: Beijing Neurosurgical Institute

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 Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Study Start: 2019-06-01
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29
• Primary Completion: 2021-06-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single-group studies	radiotherapy	All the patients received chemotherapy and radiotherapy.

Primary Outcome Measures

Name	Time	Method
Changes of white matter fibers measured by DTI after treatments.	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.	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 Outcome Measures

Name	Time	Method
Changes of muscle strength after treatments.	The muscle strength evaluation are performed at the same day before the fMRI scans.	The limb muscle strength of patients are evaluated with the Medical Research Council (MRC) scale for muscle strength (grade 0-5).

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China