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

February 25, 2013
February 27, 2013
November 12, 2018
January 16, 2013
December 2019   (Final data collection date for primary outcome measure)
  • 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
  • Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01800032 on Archive Site
  • Report descriptive statistics for FDG-PET-MRI results [ Time Frame: 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 [ Time Frame: 0, 12 months ]
Same as current
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PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
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)

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.

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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
UNC Hospitals
  • Neurofibromatosis-1
  • Optic Glioma
  • Plexiform Neurofibroma
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  • Plexiform Neurofibroma
    NF1 associated plexiform neurofibroma
  • Optic Glioma
    NF1 associated optic glioma
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
Not Provided
Principal Investigator: Timothy Gershon, MD, PhD University of North Carolina, Chapel Hill
UNC Lineberger Comprehensive Cancer Center
November 2018