Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma (NCT02584413) | Clinical Trial Compass
TerminatedNot Applicable
Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma
Stopped: Low accrual rate
United States29 participantsStarted 2013-04-16
Plain-language 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.
Who can participate
Age range
1 Year – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1