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

Intracranial Germ Cell Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03771625
• Other study ID #: 2018-GEMF-1073
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2018
• Source: Beijing Neurosurgical Institute
• Contact: Xiaoguang Qiu, M.D.
• Phone: 010-67021832
• Email: ttyy6611[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intracranial Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Intervention

Radiation:
• radiotherapy
whole brain with/without spinal cord

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of brain networks measured by BOLD-fMRI after treatments.	The brain networks during treatments are compared by functional connectivity.	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.
Primary	Changes of white matter fibers measured by DTI after treatments.	The white matter fibers damaged by tumor are evaluated by FA and MD value.	The DTI scans are performed along with the fMRI scans.
Secondary	Changes of muscle strength after treatments.	The limb muscle strength of patients are evaluated with the Medical Research Council (MRC) scale for muscle strength (grade 0-5).	The muscle strength evaluation are performed at the same day before the fMRI scans.