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Completed

NCT Number: NCT01800032

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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Key information

Conditions

Neurofibromatosis-1 Cranial Nerve Diseases Cranial Nerve Neoplasms Eye Diseases Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neurofibroma Neurofibroma, Plexiform Neuromuscular Diseases Optic Glioma Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Peripheral Nervous System Diseases Peripheral Nervous System Neoplasms Plexiform Neurofibroma

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Feb 27, 2013
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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