Overview

This trial is active, not recruiting.

Conditions neurofibromatosis-1, optic glioma, plexiform neurofibroma
Sponsor UNC Lineberger Comprehensive Cancer Center
Start date January 2013
End date November 2014
Trial size 15 participants
Trial identifier NCT01800032, LCCC1222

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
NF1 associated plexiform neurofibroma
NF1 associated optic glioma

Primary Outcomes

Measure
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions
time frame: 12 months
Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
time frame: 12 months

Secondary Outcomes

Measure
Report descriptive statistics for FDG-PET-MRI results
time frame: 0, 12 months
Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress
time frame: 0, 12 months

Eligibility Criteria

Male or female participants at least 6 years old.

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

Additional Information

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)
Principal investigator Timothy Gershon, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.