Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma
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|ClinicalTrials.gov Identifier: NCT02584413|
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment|
|Neurofibromatosis Type 1||Device: Magnetic resonance imaging Drug: Gadolinium contrast|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Hypotonia as a Clinical Predictor of Optic Pathway Glioma in Children With Neurofibromatosis Type 1|
|Actual Study Start Date :||April 16, 2013|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
Arm 1: MRI of brain with gadolinium contrast
-Eligible children whose guardians have consented to their participation will undergo routine clinical brain MRI with gadolinium contrast. The MRI scan will last no more than 45 minutes
Device: Magnetic resonance imaging
Other Name: MRIDrug: Gadolinium contrast
- Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1 [ Time Frame: At the time of MRI (1 day) ]
- A pediatric nurse practitioner (PNP) or a pediatric physician specializing in NF1, and physical therapist will screen the children for hypotonia.
- The MRI scan will show hypotonia if the children have thickening or enlargement of any portion of the optic nerve, optic chiasm, or optic tracts.
- The data analysis for this will be descriptive in nature.
- Other features that may be indicatory of OPG in children with NF1 [ Time Frame: At the time of MRI (1 day) ]
- MRI findings may include other brain tumors or T2 hyperintensities.
- The data analysis will be descriptive in nature.
- Determine if a physical therapist (PT) can train another clinical professional to accurately diagnose hypotonia [ Time Frame: 1 day ]-PTs use subjective muscle tone, a pull-to-sit test, and the presence or absence of head lag to determine hypotonia.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584413
|Contact: David Gutmann, M.D., Ph.D.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine (St. Louis Children's Hospital)||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: David Gutmann, M.D., Ph.D. 314-362-7379 email@example.com|
|Principal Investigator: David Gutmann, M.D., Ph.D.|
|Sub-Investigator: Robert McKinstry, M.D., Ph.D.|
|Sub-Investigator: Joshua Rubin, M.D., Ph.D.|
|Sub-Investigator: Joshua Shimony, M.D., Ph.D.|
|Sub-Investigator: Stephanie Morris, M.D.|
|Sub-Investigator: Courtney Dunn, P.T., D.P.T.|
|Sub-Investigator: Courtney Monroe, B.S., CRA|
|Sub-Investigator: Feng Gao, Ph.D.|
|Principal Investigator:||David Gutmann, M.D., Ph.D.||Washington University School of Medicine|