Evaluating Structural and Functional Changes of Brain by fMRI and DTI in Patients With Intracranial Germ Cell Tumors
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
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJuly 29, 2019
December 1, 2018
2 years
December 4, 2018
July 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (1)
Changes of muscle strength after treatments.
The muscle strength evaluation are performed at the same day before the fMRI scans.
Study Arms (1)
single-group studies
All the patients received chemotherapy and radiotherapy.
Interventions
whole brain with/without spinal cord
Eligibility Criteria
Patients with intracranial germ cell tumor located at the basal ganglia.
You may qualify if:
- 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;
You may not qualify if:
- patients can not tolerate MR scan;
- head motion is greater than 3 mm during functional MRI scanning.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital
Beijing, 100071, China
Related 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.
PMID: 24101738BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2018
First Posted
December 11, 2018
Study Start
June 1, 2019
Primary Completion
June 1, 2021
Study Completion
November 1, 2021
Last Updated
July 29, 2019
Record last verified: 2018-12