Functional Imaging of Cerebellar Mutism Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
New York Presbyterian Hospital
Columbia University
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01733173
First received: November 20, 2012
Last updated: June 20, 2014
Last verified: June 2014

November 20, 2012
June 20, 2014
November 2012
November 2015   (final data collection date for primary outcome measure)
investigate the feasibility of performing preoperative fMRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ≥7 of the 10 subjects successfully complete ≥60% of the functional imaging tests, we will determine the pilot study to be successful and then pursue further study.
Same as current
Complete list of historical versions of study NCT01733173 on ClinicalTrials.gov Archive Site
  • To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Functional Imaging of Cerebellar Mutism Syndrome
Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects for this study will be offered participation once they are referred to members of the Departments of Neurosurgery or Pediatrics at the NYPH/WCMC or MSKCC.

Brain Mass
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.
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.
Intervention: Procedure: MRI with DTI and fMRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
November 2015
November 2015   (final data collection date for primary outcome measure)

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

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)
Both
3 Years to 21 Years
No
Contact: Robert J. Young, MD 212-639-8196
Contact: Yasmin Khakoo, MD 212-639-8292
United States
 
NCT01733173
12-121
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • New York Presbyterian Hospital
  • Columbia University
  • Weill Medical College of Cornell University
Principal Investigator: Robert J. Young, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP