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

NCT01800032 | Completed DMC

• 1 other identifier: LCCC1222
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis-1; Optic Glioma; Plexiform Neurofibroma

Outcome Measures

Primary Outcomes (2)

• 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

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

  12 months

Secondary Outcomes (2)

• Report descriptive statistics for FDG-PET-MRI results

  0, 12 months

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

  0, 12 months

Study Arms (2)

Plexiform Neurofibroma

NF1 associated plexiform neurofibroma

Optic Glioma

NF1 associated optic glioma

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UNC Hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Optic Nerve Glioma; Neurofibroma, Plexiform

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Eye Diseases; Neurofibroma; Nerve Sheath Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Timothy Gershon, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: January 16, 2013
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2019
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

US (1)