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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)


N/A
6 Years
N/A
Open (Enrolling)
Both
Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma

Thank you

Trial Information

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)


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions

Outcome Description:

Ratios of SUVmax values within a group of patients who all have progressive disease

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Timothy Gershon, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

LCCC1222

NCT ID:

NCT01800032

Start Date:

January 2013

Completion Date:

November 2014

Related Keywords:

  • Neurofibromatosis-1
  • Optic Glioma
  • Plexiform Neurofibroma
  • Glioma
  • Neurofibroma
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica
  • Neurofibroma, Plexiform
  • Optic Nerve Glioma

Name

Location

University of North Carolina-Chapel HillChapel Hill, North Carolina  27599