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

NCT ID: NCT03771625

Last Updated: 2019-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Germ Cell Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single-group studies

All the patients received chemotherapy and radiotherapy.

radiotherapy

Intervention Type RADIATION

whole brain with/without spinal cord

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiotherapy

whole brain with/without spinal cord

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

chemotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Neurosurgical Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tiantan Hospital

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaoguang Qiu, M.D.

Role: CONTACT

010-67021832

Shuai Liu, M.D.

Role: CONTACT

010-67021832

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shuai Liu, M.D.

Role: primary

+861059975266

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24101738 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-GEMF-1073

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

68Ga-P16-093 PET/CT Imaging in Glioma Patients
NCT05569434 UNKNOWN PHASE1/PHASE2