Functional Imaging of Cerebellar Mutism Syndrome

NCT01733173 | Completed

• 1 other identifier: 12-121
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Mass

Keywords

mass in posterior fossa; benign; malignant; surgical resection; MRI; fMRI; DTI; 12-121

Outcome Measures

Primary Outcomes (1)

• investigate the feasibility of performing preoperative fMRI

  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.

  1 year

Secondary Outcomes (2)

• 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 Arms (1)

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

Interventions

MRI with DTI and fMRI PROCEDURE

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

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

MSK clinics

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological

Study Officials

• Robert J. Young, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: November 1, 2012
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

US (1)