PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
Completed
Conditions studied: Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma
In brief
This prospective pilot study is designed to provide preliminary data on the use of Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) in patients with neurofibromatosis-1 (NF1) associated optic glioma and plexiform neurofibroma (PN). Subjects will undergo FDG-PET-MRI scans in place of standard of care imaging at 0 and 12 months, unless more frequent imaging is clinically indicated. Subjects and their family caregivers will also undergo serial interviews and complete questionnaires related to the psychosocial aspects of NF1.
Key facts
- Study ID
- NCT01800032
- Run by
- UNC Lineberger Comprehensive Cancer Center
- People needed
- 30
- Starts
- 2013-01-16
- Expected to finish
- 2019-12-05
- Last updated by the study team
- 2021-05-12
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of North Carolina-Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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