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

Sponsor
Beijing Neurosurgical Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03771625
Collaborator
(none)
30
Enrollment
1
Location
29
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: radiotherapy

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 [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
single-group studies

All the patients received chemotherapy and radiotherapy.

Radiation: radiotherapy
whole brain with/without spinal cord
Other Names:
  • chemotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Secondary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tiantan Hospital Beijing China 100071

    Sponsors and Collaborators

    • Beijing Neurosurgical Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Beijing Neurosurgical Institute
    ClinicalTrials.gov Identifier:
    NCT03771625
    Other Study ID Numbers:
    • 2018-GEMF-1073
    First Posted:
    Dec 11, 2018
    Last Update Posted:
    Jul 29, 2019
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Beijing Neurosurgical Institute
    fMRI
    DTI
    Intracranial Germ cell tumor
    Basal ganglia
    Additional relevant MeSH terms:
    Neoplasms, Germ Cell and Embryonal

    Study Results

    No Results Posted as of Jul 29, 2019