Observing the progression of neurofibromatosis type 2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to understand the factors that contribute to tumor progression and the neurological burden associated with neurofibromatosis type 2 (NF2). A total of 269 participants aged 8 to 75, diagnosed with NF2 either clinically or genetically, will undergo thorough physical and neurological examinations, including MRI scans and blood collection. Participants will be followed for up to ten years with annual evaluations, including auditory and vestibular assessments for those with measurable hearing and untreated vestibular schwannomas. The study seeks to gather comprehensive data to better understand NF2 and its impact on patients.

Why it matters

Who can join: the full rules

* 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 that involves metal clips or wires, which might be expected to cause tissue damage or produce image artifacts such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, and artificial heart valves.
* ABIs or cochlear implants are not approved by the NIH Radiology department for safe use on NIH scanners..
* Have severe chronic renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73 m2), hepatorenal syndrome or post-liver transplantation.
* Are pregnant at time of intake visit (women of childbearing age will be tested with a urine pregnancy test).

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Prashant Chittiboina, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
• Study coordinator: Christina P Hayes, C.R.N.P.
• Email: christi.hayes@nih.gov
• Phone: (301) 496-2921

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imlygic (T-VEC) injections for cutaneous neurofibromas in adults with NF1

  This trial will test whether injecting Imlygic into bothersome cutaneous neurofibromas can shrink them or reduce symptoms in adults with NF1 who want local treatment.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT07102394

• Clinical and demographic characteristics of adults with neurofibromatosis in Russia

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• Observing the health management of patients with rare genetic syndromes

  This study looks at how patients with rare genetic syndromes like Prader-Willi and Klinefelter manage their health as they move from children's care to adult care to see what support they need.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT04463316

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.