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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT01800032
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with neurofibromatosis-1 with either optic glioma, due for imaging scan, or plexiform neurofibroma, due for imaging secondary to clinical signs or symptoms of progressive disease
* ≥ 6 years of age
* English-speaking
* If female of child-bearing potential, negative urine pregnancy test performed within 7 days prior to each FDG-PET-MRI
* Study-specific informed consent or assent obtained and signed
Exclusion Criteria:
* Unable to undergo FDG-PET-MRI without sedation
* Currently undergoing chemotherapy for progressing optic glioma
* Pregnant or lactating female
* Poorly controlled diabetes mellitus
* Presence of pacemaker, intracranial aneurysm clip, cochlear implant, metal halo device, epicardial pacemaker leads, or any other device that makes MRI unsafe
* Serum creatinine \> 1.8 mg/dL OR GFR \< 30 mL/min
* Unable to lie flat for \> 1 hour
* Body Mass Index (BMI) \> 35
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01800032
Study Brief:
Protocol Section:
NCT01800032