- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733173
Functional Imaging of Cerebellar Mutism Syndrome
October 12, 2021 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
MSK clinics
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
investigate the feasibility of performing preoperative fMRI
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography
Time Frame: 1 year
|
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
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1 year
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To investigate potential changes in DTI after posterior fossa surgery
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert J. Young, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
October 12, 2021
Study Completion (Actual)
October 12, 2021
Study Registration Dates
First Submitted
November 20, 2012
First Submitted That Met QC Criteria
November 20, 2012
First Posted (Estimate)
November 26, 2012
Study Record Updates
Last Update Posted (Actual)
October 13, 2021
Last Update Submitted That Met QC Criteria
October 12, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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