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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
时间窗: 12 months
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions
时间窗: 12 months
Ratios of SUVmax values within a group of patients who all have progressive disease
次要结局
- Report descriptive statistics for FDG-PET-MRI results(0, 12 months)
- Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress(0, 12 months)