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
  Purpose

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.


Condition Intervention
Brain Mass
Procedure: MRI with DTI and fMRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733173

Contacts
Contact: Robert J. Young, MD 212-639-8196
Contact: Yasmin Khakoo, MD 212-639-8292

Locations
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         
New York Presbyterian Hospital-Weill Medical College of Cornell University Not yet recruiting
New York, New York, United States, 10065
Contact: Ajay Gupta, MD         
Principal Investigator: Ajay Gupta, MD         
Columbia University Medical Center Not yet recruiting
New York, New York, United States
Contact: Stephen Sands, PhD         
Principal Investigator: Stephen Sands, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Columbia University
Weill Medical College of Cornell University
Investigators
Principal Investigator: Robert J. Young, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01733173     History of Changes
Other Study ID Numbers: 12-121
Study First Received: November 20, 2012
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
mass in posterior fossa
benign
malignant
surgical resection
MRI
fMRI
DTI
12-121

ClinicalTrials.gov processed this record on August 20, 2014