Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- MIB Positive (Percent)
研究概览
简要总结
Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA Office of Orphan Product Development (OOPD)
详细描述
Although pediatric central nervous system tumors are rare, they are a significant contributor to morbidity and mortality in children. Tumor staging, detecting recurrent tumor, and assessing the response to therapy are critical in the treatment of brain tumors, but current imaging methods have major limitations in providing such information. The objective of this study is to validate 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) as a measure of tumor proliferation and to demonstrate the utility of 18F-FLT as a PET imaging agent in children with central nervous system tumors. The proposed studies will evaluate 18F-FLT PET in three groups:
- Children with a new diagnosis of central nervous system tumor.
- Children in whom conventional imaging has raised concern for possible recurrence of a central nervous system tumor.
- Children receiving post-operative chemotherapy for a central nervous system tumor.
In these three groups, correlation of 18F-FLT uptake with tumor histopathology and patient outcome will be used to assess the utility of 18F-FLT for grading tumors at diagnosis, for accurate identification of tumor recurrence, and for early assessment of the response to chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 21 years or less
- •capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility)
- •Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater
- •Patients receiving steroids and/or anti-seizure medications are eligible
排除标准
- •clinically active infection
- •pregnancy or breast-feeding
- •serious intercurrent medical illness
- •require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging
研究组 & 干预措施
New diagnosis of brain tumor
In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using [18F] FLT.
干预措施: [18F] FLT (Drug)
Possible recurrent brain tumor
In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using [18F] PET.
干预措施: [18F] FLT (Drug)
Brain tumor response to chemotherapy
In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using [18F] FLT before the start and after two cycles of chemotherapy.
Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment.
干预措施: [18F] FLT (Drug)
结局指标
主要结局
MIB Positive (Percent)
时间窗: 30 days
On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining
[18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation
时间窗: on average 1 week
\[18F\] FLT uptake, as determined by pre-operative positron emission tomography (PET) imaging, will be compared to histological markers of cellular proliferation in the resected brain tumor. This will be performed in three groups of subjects (3 arms): (1)children with newly diagnosed central nervous system tumors, (2) children in whom there is concern for recurrence of central nervous system tumor,(3) children with central nervous system tumors that are treated with post-operative chemotherapy.
次要结局
- Biodistribution of [18F]FLT(6 hours)
- Preliminary Evaluation of Clinical Utility of [18F] FLT PET(3 months)
研究者
Frederick Daniel Grant
Assistant Professor in Radiology
Boston Children's Hospital