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

This study is currently recruiting participants.
Verified February 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01800032
First received: February 25, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Report descriptive statistics for FDG-PET-MRI results [ Time Frame: 0, 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Plexiform Neurofibroma
NF1 associated plexiform neurofibroma
Optic Glioma
NF1 associated optic glioma

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01800032

Contacts
Contact: Dorothy Riguera, BS 919-843-5420 riguera@email.unc.edu

Locations
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dorothy Riguera, BS     919-843-5420     riguera@email.unc.edu    
Principal Investigator: Timothy Gershon, MD, PhD            
Sub-Investigator: Julie Blatt, MD            
Sub-Investigator: Stuart Gold, MD            
Sub-Investigator: Robert Greenwood, MD            
Sub-Investigator: J. Keith Smith, MD, PhD            
Sub-Investigator: Amir Khandani, MD            
Sub-Investigator: Sheila Santacroce, PhD            
Sub-Investigator: Hong Yuan, PhD            
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Timothy Gershon, MD, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01800032     History of Changes
Other Study ID Numbers: LCCC1222
Study First Received: February 25, 2013
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on May 19, 2013