PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Brain Cancer |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 11/14/2018 |
| Start Date: | January 16, 2013 |
| End Date: | December 2019 |
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.
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.
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
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