Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1 and High Plexiform Neurofibroma Tumor Burden
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To determine if WBMRI can be used to identify ANF in NF1 patients with high tumor burden.
研究概览
简要总结
This study is being conducted to determine if Whole Body MRI (WBMRI) can be used to identify Atypical Neurofibromas (ANF) in Neurofibromatosis Type 1 (NF1) patients with high tumor burden. Each enrolled participant will have two (2) WBMRIs without sedation during the study period. Eligible participants must be Male or Female between the ages of 8-30 with diagnosed NF1; with one or more PN greater than 3cm in diameter and willing to comply with study procedures.
详细描述
This is a study to determine the feasibility of using Whole Body MRI (WBMRI) to detect Atypical Plexiform Neurofibromas (ANF) among Neurofibromatosis Type 1 (NF1) patients who are at highest risk for developing these tumors. In order to do this, the investigators will prospectively obtain WBMRI scans on patients with high plexiform tumor burden (which investigators will define as >=1 plexiform neurofibroma (PN) that is >3cm in diameter on MRI) at the same time as their regularly scheduled MRI to allow for radiographic comparison of the identified PNs. In this study, the investigators will plan to establish a method that effectively characterizes PNs in terms of their volume, radiographic appearance on WBMRI and association with clinical characteristics.
As an exploratory aim, the investigators plan to collect blood samples from each patient at the same time as the MRI to determine the feasibility of isolating cfDNA (circulating free DNA) from plasma of patients with high plexiform tumor burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between 8-30 years of age
- •Confirmed diagnosis of NF1
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Prior MRI documentation confirming >=1 PN that is >3cm in diameter
排除标准
- •Unable to undergo MRI without sedation
- •Presence of metal or other devices that are contraindicated for MRI
结局指标
主要结局
To determine if WBMRI can be used to identify ANF in NF1 patients with high tumor burden.
时间窗: 2-3 years
Number of NF1 participants with high tumor burden who have ANF on WBMRI
次要结局
- Determine if clinical signs and symptoms correlate with tumor burden and/or the presence of ANF on WBMRI(2-3 years)
研究者
Miriam Bornhorst
Assistant Professor Division of Oncology and Center for Genetics Medicine
Children's National Research Institute