Functional Imaging of Cerebellar Mutism Syndrome
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|ClinicalTrials.gov Identifier: NCT01733173|
Recruitment Status : Recruiting
First Posted : November 26, 2012
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment|
|Brain Mass||Procedure: MRI with DTI and fMRI|
|Study Type :||Observational|
|Estimated Enrollment :||7 participants|
|Official Title:||Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
mass in posterior fossa, either benign or malignant
A pilot study will be performed. We will perform fMRI and DTI in children before and after surgery for posterior fossa brain tumors. Each subject will receive the standard of care for their brain tumors in terms of surgical resection, radiation therapy and/or chemotherapy.
Procedure: MRI with DTI and fMRI
When possible, the subject will undergo a post operative fMRI/ DTI scan as well as clinical language testing. If the subject develops CMS, the second fMRI will be performed as soon as possible. Some subjects may be severely impaired or have difficulty performing fMRI and clinical language testing tasks. In these instances, the fMRI and language testing may not be performed, or we may choose to perform resting state or passive fMRI tasks instead.
- investigate the feasibility of performing preoperative fMRI [ Time Frame: 1 year ]in young children at risk for developing CMS after posterior fossa brain tumor resection. Age appropriate language functional MRI tasks targeting the cerebellar language centers will be performed in children before surgery and correlated with formal neuropsychological and language testing. The fMRI will be repeated after surgery. If ≥5 of the 7 subjects successfully complete ≥60% of the functional imaging tests, we will determine the pilot study to be successful and then pursue further study.
- To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography [ Time Frame: 1 year ]in subjects who develop CMS after brain tumor resection. Injury to cerebro-cerebellar tracts such as the dentatothalamocortical tracts has been implicated in the development of CMS. We propose studying the proximity between important language white matter paths and the surgical intervention before surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the preoperative scan
- To investigate potential changes in DTI after posterior fossa surgery [ Time Frame: 1 year ]that may correlate with the development of CMS. We hypothesize that measurements of water diffusion by DTI and tractography will be altered in subjects who develop CMS, even without striking anatomical changes after surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the postoperative scan. The preoperative and postoperative DTI results will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733173
|Contact: Robert J. Young, MD||212-639-8196|
|Contact: Yasmin Khakoo, MD||212-639-8292|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Robert J. Young, MD 212-639-8196|
|Contact: Yasmin Khakoo, MD 212-639-8292|
|Principal Investigator: Robert J. Young, MD|
|Principal Investigator:||Robert J. Young, MD||Memorial Sloan Kettering Cancer Center|