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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01800032
Recruitment Status : Active, not recruiting
First Posted : February 27, 2013
Last Update Posted : November 12, 2018
Information provided by (Responsible Party):
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.

Condition or disease
Neurofibromatosis-1 Optic Glioma Plexiform Neurofibroma

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : January 16, 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Plexiform Neurofibroma
NF1 associated plexiform neurofibroma
Optic Glioma
NF1 associated optic glioma

Primary Outcome Measures :
  1. 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

  2. Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Report descriptive statistics for FDG-PET-MRI results [ Time Frame: 0, 12 months ]
    SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio

  2. Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress [ Time Frame: 0, 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UNC Hospitals

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01800032

United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Timothy Gershon, MD, PhD University of North Carolina, Chapel Hill

Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT01800032     History of Changes
Other Study ID Numbers: LCCC1222
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Neurofibromatosis 1
Neurofibroma, Plexiform
Optic Nerve Glioma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Neoplasms by Site
Cranial Nerve Diseases
Optic Nerve Diseases
Eye Diseases