Clinical Trial: PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: 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)
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.
Detailed Summary:
Sponsor: UNC Lineberger Comprehensive Cancer Center
Current Primary Outcome:
- 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
- Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Report descriptive statistics for FDG-PET-MRI results [ Time Frame: 0, 12 months ]SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio
- Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress [ Time Frame: 0, 12 months ]
Original Secondary Outcome: Same as current
Information By: UNC Lineberger Comprehensive Cancer Center
Dates:
Date Received: February 25, 2013
Date Started: January 2013
Date Completion: June 2017
Last Updated: July 14, 2016
Last Verified: July 2016
