Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
研究概览
简要总结
This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and diagnose brain tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine if 68Ga-DOTATOC (gallium Ga 68-edotreotide) PET when combined with magnetic resonance imaging (MRI) will differentiate embryonal tumors such as medulloblastoma and supratentorial primitive neuroectodermal tumor (PNET) from the low and high grade gliomas.
II. To determine if 68Ga-DOTATOC PET will aid in the identification of residual tumor post operatively in those patients who were 68Ga-DOTATOC PET positive prior to surgery.
OUTLINE:
Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.
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
- 6 Months 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with brain tumors will be eligible for this study
- •Eligible subjects must be able and willing to undergo the procedures of the study
- •Electronic version of pre-surgery MRI must be available for co-registration purposes
- •Fresh frozen tumor, and/or paraffin block of biopsy or resected tumor is recommended, but not required to determine expression of somatostatin receptors in tumor by immunohistochemistry and/or quantitative polymerase chain reaction (qPCR)
排除标准
- •Women who are pregnant or breastfeeding
- •Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin of body that would preclude obtaining an MRI as part of the initial study evaluation
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons
- •Presence of any additional medical condition such as inter-current illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
结局指标
主要结局
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
时间窗: Up to 30 days
Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide
时间窗: Baseline up to 30 days
The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -).
次要结局
未报告次要终点
研究者
Sue O'Dorisio
Professor Pediatrics-HEM-Oncology
University of Iowa