Hypotonia as a Clinical Predictor of Optic Pathway Glioma in Children With Neurofibromatosis Type 1

Status: Terminated
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 7
Healthy Volunteers: f
View:

• 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

Locations
United States
Missouri
Washington University School of Medicine (St. Louis Children's Hospital)
Saint Louis
Time Frame
Start Date: 2013-04-16
Completion Date: 2019-02-07
Participants
Target number of participants: 29
Treatments
Experimental: 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
Sponsors
Leads: Washington University School of Medicine
Collaborators: St. Louis Children's Hospital

This content was sourced from clinicaltrials.gov