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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01800032
First Posted: February 27, 2013
Last Update Posted: October 4, 2017
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.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
  Purpose

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
Neurofibromatosis-1 Optic Glioma Plexiform Neurofibroma

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Actual Study Start Date: January 16, 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Plexiform Neurofibroma
NF1 associated plexiform neurofibroma
Optic Glioma
NF1 associated optic glioma

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01800032


Locations
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
Investigators
Principal Investigator: Timothy Gershon, MD, PhD University of North Carolina, Chapel Hill
  More Information

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01800032     History of Changes
Other Study ID Numbers: LCCC1222
First Submitted: February 25, 2013
First Posted: February 27, 2013
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibroma
Neurofibroma, Plexiform
Neurofibromatosis 1
Nerve Sheath Neoplasms
Optic Nerve Glioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Glioma
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