Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography- Magnetic Resonance Imaging (FDG-PET-MRI) in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
N/A
6 Years
N/A
6 Years
N/A
Open (Enrolling)
Both
Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma
Both
Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma
Trial Information
Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography- Magnetic Resonance Imaging (FDG-PET-MRI) in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions
Outcome Description:
Ratios of SUVmax values within a group of patients who all have progressive disease
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Timothy Gershon, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of North Carolina, Chapel Hill
Authority:
United States: Institutional Review Board
Study ID:
LCCC1222
NCT ID:
NCT01800032
Start Date:
January 2013
Completion Date:
November 2014
Related Keywords:
- Neurofibromatosis-1
- Optic Glioma
- Plexiform Neurofibroma
- Glioma
- Neurofibroma
- Neurofibromatoses
- Neurofibromatosis 1
- Osteitis Fibrosa Cystica
- Neurofibroma, Plexiform
- Optic Nerve Glioma
Name | Location |
|---|---|
| University of North Carolina-Chapel Hill | Chapel Hill, North Carolina 27599 |
