Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00598351
Eligibility Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
75 Years
Study:
NCT00598351
Study Brief:
Protocol Section:
NCT00598351