Clinical trial · Interventional
Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma
Hypotonia as a Clinical Predictor of Optic Pathway Glioma in Children With Neurofibromatosis Type 1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadolinium contrast | Drug | — | UNRESOLVED |
| Magnetic resonance imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1: MRI of brain with gadolinium contrast
- description
- -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
- interventionNames
- Device: Magnetic resonance imaging
- Drug: Gadolinium contrast
Primary outcomes (1)
- measure
- Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1
- timeFrame
- At the time of MRI (1 day)
- description
- * 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 7 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available