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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurofibromatosis-1
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
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
Outcomes
Primary Outcomes
Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
Time Frame: 12 months
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions
Time Frame: 12 months
Ratios of SUVmax values within a group of patients who all have progressive disease
Secondary Outcomes
- Report descriptive statistics for FDG-PET-MRI results(0, 12 months)
- Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress(0, 12 months)