PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)

UNC Lineberger Comprehensive Cancer Center30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neurofibromatosis-1 Optic Glioma Plexiform Neurofibroma

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions

Ratios of SUVmax values within a group of patients who all have progressive disease

Time frame: 12 months

Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease

Time frame: 12 months

Secondary Outcomes

Report descriptive statistics for FDG-PET-MRI results

SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio

Time frame: 0, 12 months

Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress