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Low accrual rate
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| Name | Class |
|---|---|
| St. Louis Children's Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: MRI of brain with gadolinium contrast | Experimental | -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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging | Device | -Standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1 |
| At the time of MRI (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gutmann, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine (St. Louis Children's Hospital) | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D009456 | Neurofibromatosis 1 |
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| C120577 | gadolinium compound P760 |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Gadolinium contrast | Drug | -Standard of care |
|
-PTs use subjective muscle tone, a pull-to-sit test, and the presence or absence of head lag to determine hypotonia. |
| 1 day |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |