Hypotonia as a Clinical Predictor of Optic Pathway Glioma in Children With Neurofibromatosis Type 1
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Magnetic resonance imaging (Device)
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
干预措施: Gadolinium contrast (Drug)
结局指标
主要结局
Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1
时间窗: At the time of MRI (1 day)
* 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.
次要结局
- Other features that may be indicatory of OPG in children with NF1(At the time of MRI (1 day))
- Determine if a physical therapist (PT) can train another clinical professional to accurately diagnose hypotonia(1 day)