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Clinical Trials/NCT01733173
NCT01733173
Completed
Not Applicable

Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome

Memorial Sloan Kettering Cancer Center1 site in 1 country4 target enrollmentNovember 2012
ConditionsBrain Mass

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Mass
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
4
Locations
1
Primary Endpoint
investigate the feasibility of performing preoperative fMRI
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to better understand why some children with cancer have difficulty speaking after brain surgery. Difficulty speaking may be due to known complications to the language centers in the brain. These language centers may be located in slightly different places in different people. This study will study which areas may be damaged.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
October 12, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subject and/or guardian is able to provide written informed consent prior to study registration
  • Age ≥3 years and ≤21 years
  • Newly diagnosed, untreated mass in posterior fossa, either benign or malignant
  • Is being evaluated for surgical resection of the mass
  • Able to perform clinical language testing in English

Exclusion Criteria

  • Claustrophobia
  • Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
  • Pregnant or nursing female
  • Does not speak English as a primary language (as determined by the P.I. or treating physician after discussion with a potential subject and his/her family)
  • Preexisting language or developmental disorder that would limit ability to cooperate with testing (as determined by the P.I. or treating physician after interviewing potential subject and his/her family; for example, a child may be excluded if he/she has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp, hypotonia, or other age inappropriate speech development)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography(1 year)
  • To investigate potential changes in DTI after posterior fossa surgery(1 year)

Study Sites (1)

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