TerminatedNot Applicable

Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma

Stopped: Low accrual rate

United States29 participantsStarted 2013-04-16

Plain-language summary

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.

Who can participate

Age range1 Year – 7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1

Timeframe: At the time of MRI (1 day)

Trial details

NCT IDNCT02584413

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-07