- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01800032
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina-Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Plexiform Neurofibroma
NF1 associated plexiform neurofibroma
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Optic Glioma
NF1 associated optic glioma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions
Time Frame: 12 months
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Ratios of SUVmax values within a group of patients who all have progressive disease
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12 months
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Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Report descriptive statistics for FDG-PET-MRI results
Time Frame: 0, 12 months
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SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio
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0, 12 months
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Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress
Time Frame: 0, 12 months
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0, 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Timothy Gershon, MD, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Nerve Sheath Neoplasms
- Neurocutaneous Syndromes
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Optic Nerve Neoplasms
- Neurofibromatoses
- Neurofibromatosis 1
- Neurofibroma
- Neurofibroma, Plexiform
- Optic Nerve Glioma
Other Study ID Numbers
- LCCC1222
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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