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

Plexiform Neurofibroma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800032
• Other study ID #: LCCC1222
• Status: Completed
• Start date: January 16, 2013
• Est. completion date: December 5, 2019

Study information

• Verified date: May 2021
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibroma, Plexiform
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis-1
• Optic Glioma
• Optic Nerve Glioma
• Plexiform Neurofibroma

Locations

Country	Name	City	State
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease		12 months
Secondary	Report descriptive statistics for FDG-PET-MRI results	SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio	0, 12 months
Secondary	Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress		0, 12 months