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

Completed

• Conditions: Plexiform Neurofibroma; Neurofibromatosis-1; Optic Glioma

• Registration Number: NCT01800032
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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 Description

Not available

Study Timeline

• Study Start: 2013-01-16
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Primary Completion: 2018-12-05
• Study Completion: 2019-12-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease	12 months
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions	12 months	Ratios of SUVmax values within a group of patients who all have progressive disease

Secondary Outcome Measures

Name	Time	Method
Report descriptive statistics for FDG-PET-MRI results	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	0, 12 months

Trial Locations

Locations (1)

University of North Carolina-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States