Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-16

Study Completion Date

2019-02-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Neurofibromatosis Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Magnetic resonance imaging

Intervention Type DEVICE

-Standard of care

Gadolinium contrast

Intervention Type DRUG

-Standard of care

Interventions

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Magnetic resonance imaging

-Standard of care

Intervention Type DEVICE

Gadolinium contrast

-Standard of care

Intervention Type DRUG

Other Intervention Names

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MRI

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No