PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
NCT ID: NCT01800032
Last Updated: 2021-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2013-01-16
2019-12-05
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Plexiform Neurofibroma
NF1 associated plexiform neurofibroma
No interventions assigned to this group
Optic Glioma
NF1 associated optic glioma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
6 Years
ALL
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Timothy Gershon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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LCCC1222
Identifier Type: -
Identifier Source: org_study_id
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