Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02584413|
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : March 19, 2018
|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: MRI
Drug: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584413
|Contact: David Gutmann, M.D., Ph.D.||email@example.com|
|United States, Missouri|
|Washington University School of Medicine (St. Louis Children's Hospital)||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: David Gutmann, M.D., Ph.D. 314-362-7379 firstname.lastname@example.org|
|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|