Natural History Study of Patients With Neurofibromatosis Type 2
Objective With this prospective natural experiment trial on neurofibromatosis type 2 (NF2) study, we hope to understand the factors leading to tumor progression and neurological disease burden in NF2. Study Population A total of 269 participants, ages 8-75, with a clinical or genetic diagnosis of NF2 will participate i
| Condition(s) | Neurofibromatosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Objective With this prospective natural experiment trial on neurofibromatosis type 2 (NF2) study, we hope to understand the factors leading to tumor progression and neurological disease burden in NF2. Study Population A total of 269 participants, ages 8-75, with a clinical or genetic diagnosis of NF2 will participate in this study. Design Study participants will be evaluated with a thorough physical and neurologic examination upon enrollment. This initial outpatient evaluation will include magnetic resonance imaging with contrast of brain and spine and blood collection for research use. Participants with measurable hearing will have audiology assessment performed. Participants with untreated vestibular schwannomas will have vestibular assessment performed during the initial visit. Genetic |
| Who can participate | * INCLUSION CRITERIA: To be eligible for entry into the study, candidates must meet all the following criteria: * Have the diagnosis of NF2 by established clinical criteria or genetic testing. * Be between the age of 8 and 75. * Have the capacity to undergo serial MRI scanning of the CNS without IV sedation. * Able to give informed consent, or have a parent able to provide informed consent if a child. EXCLUSION CRITERIA: Candidates will be excluded if they: * Have a clinically unstable condition that precludes serial clinical and imaging evaluation (i.e. Class 3 congestive heart failure, severe chronic renal insufficiency, severe chronic obstructive pulmonary disease). * Cannot have an MRI scan due to an allergy or relative contraindication to MRI contrast agents, prior surgery or implant |
| Ages | 8 Years to 75 Years |
| Sex | All |
| Lead sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Locations | Bethesda, Maryland, United States |
| Start date | 2008-03-21 |
| NCT ID | NCT00598351 |
| Official listing | https://clinicaltrials.gov/study/NCT00598351 |