Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma

Stopped early · Not applicable

Conditions studied: Neurofibromatosis Type 1

In brief

Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during annual ophthalmologic exams. However, because these exams are annual, it is possible for healthcare providers to miss the point at which a child's vision begins to decline (potentially indicating an OPG). If at-risk children are screened for hypotonia early in life, those children who are hypotonic may undergo magnetic resonance imaging (MRI) to evaluate for OPG before they are showing ophthalmologic symptoms. This would enable healthcare providers to discover vision loss earlier and treat symptomatic OPGs earlier, thereby allowing us a better chance of preventing further vision loss in children with OPGs.

Key facts

Study ID: NCT02584413
Run by: Washington University School of Medicine
People needed: 29
Starts: 2013-04-16
Expected to finish: 2019-02-07
Last updated by the study team: 2019-09-03

Who can join

Age: 1 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must be seen at the St. Louis Children's Hospital NF Clinic
Diagnosis of NF1
Between 1 and 7 years of age, inclusive
Diagnosed with hypotonia
Legally authorized representative/guardian must be able to understand and willing to sign an IRB-approved informed consent document
Must have an MRI scan ordered by a treating physician

You may not qualify if…

Normal tone on clinical exam
Known allergy to gadolinium or the sedative, propofol, used during MRI
Poor kidney function defined as a known renal disease or elevated BUN and creatine
Requiring intubation for anesthesia

Where it is running

Washington University School of Medicine (St. Louis Children's Hospital) — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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