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Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome


N/A
6 Years
21 Years
Open (Enrolling)
Both
Brain Mass

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Trial Information

Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome


Inclusion Criteria:



- Subject and/or guardian is able to provide written informed consent prior to study
registration

- Age ≥6 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 tolerate MRI without sedation

- Able to perform fMRI tasks

- 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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

investigate the feasibility of performing preoperative fMRI

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Robert J. Young, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-121

NCT ID:

NCT01733173

Start Date:

November 2012

Completion Date:

November 2014

Related Keywords:

  • Brain Mass
  • mass in posterior fossa
  • benign
  • malignant
  • surgical resection
  • MRI
  • fMRI
  • DTI
  • 12-121

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Columbia University Medical Center New York, New York  10032
New York Presbyterian Hospital-Weill Medical College of Cornell University New York, New York  10065