Novel Imaging Modalities For Plexiform Neurofibromas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
研究概览
简要总结
RATIONALE: New imaging procedures such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) and magnetic resonance (MR) perfusion imaging may improve the ability to detect disease progression, help doctors predict a patient's response to treatment, and help plan the most effective treatment.
PURPOSE: This diagnostic trial is studying how well FDG-PET and MR perfusion imaging work in finding disease progression and determining response to treatment in patients with neurofibromatosis 1 and plexiform neurofibroma.
详细描述
OBJECTIVES:
- Determine whether fludeoxyglucose F 18 positron emission tomography (FDG-PET) and MR perfusion studies can predict plexiform neurofibroma growth rates in patients with neurofibromatosis 1.
- Determine whether FDG-PET and MR perfusion studies can predict the likelihood of response in patients who are undergoing investigational treatment for plexiform neurofibromas.
- Identify neuroimaging characteristics that distinguish patients who have responded to therapy from those who have not after completion of treatment.
OUTLINE:
- Stratum 1: Patients undergo MR perfusion scan with gadopentetate dimeglumine and fludeoxyglucose F 18 positron emission tomography (FDG-PET) at baseline and quantitative MRI evaluation at baseline and 1 year.
- Stratum 2: Patients undergo quantitative MRI, MR perfusion scan with gadopentetate dimeglumine, and FDG-PET at baseline and 1 year.
PROJECTED ACCRUAL: A total of 48 patients (32 for stratum 1 and 16 for stratum 2) will be accrued for this study.
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
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Stratum 1:
- •Diagnosis of neurofibromatosis 1 (NF1) and plexiform neurofibromas
- •At high risk for progression, as defined by any of the following:
- •Anatomic location such that progression carries a high risk of impairment of function, pain, or disfigurement (e.g., neck/mediastinum, paraspinal nerve roots, orbit, and face)
- •Tumors that the patient, family, or caregiver believes have increased in size within the past year, but appear stable by standard clinical or radiographic measures
- •No plexiform neurofibromas that are small, cause no pain or functional impairment, or are not likely to cause pain or functional impairment over the succeeding 12 months
- •Stratum 2:
- •Diagnosis of NF1 and progressive plexiform neurofibromas
- •Neurofibroma progression documented by increase in lesion size on MRI
- •Currently being enrolled on a clinical therapeutic trial at Children's Hospital of Philadelphia
- •PATIENT CHARACTERISTICS:
- •25 and under
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Stratum 1:
- •No prior or concurrent chemotherapy
- •No concurrent enrollment on a chemotherapy clinical trial
- •Stratum 2:
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 6 weeks since prior radiotherapy (stratum 2)
- •Prior surgery for progressive plexiform neurofibroma allowed if incompletely resected and measurable disease remains (stratum 2)
排除标准
- 未提供
研究组 & 干预措施
18FDG-PET scan and MR perfusion
Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
干预措施: fludeoxyglucose F 18 (Radiation)
18FDG-PET scan and MR perfusion
Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
干预措施: gadopentetate dimeglumine (Radiation)
结局指标
主要结局
Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
时间窗: One year
We correlated SUVmax and change in tumor volume over the subsequent year
次要结局
未报告次要终点