18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Adverse event rate
研究概览
简要总结
PET (positron emission tomography) scans combined with a radioactive tracer will be used to identify and analyze tumors. Currently, the most common tracer used to analyze neuroblastoma tumors is called 123I-mIBG. However, the picture it provides is not always clear enough to see the very small areas of the disease.
18F-DA (18F-fluorodopamine) has been shown to be safe and more effective than 123I-mIBG in analyzing the tumor pheochromocytoma, which is closely related to neuroblastoma.
With this research study, the investigators plan to meet the following goals:
- Investigate to see if 18F-DA is safe to administer to pediatric patients with known or suspected neuroblastoma or pheochromocytoma
- Examine where in the body 18F-DA goes.
- Obtain information comparing 18F-DA to 123I-mIBG to see if 18F-DA could replace 123I-mIBG in the future.
About 20 people, with known or suspected neuroblastoma or pheochromocytoma, will take part in this Pilot study at St. Jude.
详细描述
Neuroblastoma is the most common extracranial malignant tumor of childhood. Nuclear imaging with 123I-mIBG is the standard test to follow and manage these patients. Because of the inherent imaging characteristics of I-123, there is suboptimal resolution within the images, causing them to appear somewhat blurry, which reduces our ability to find small areas of disease. A chemical that uses positron emission tomography should allow much better resolution of the images, which could improve patient care by allowing us to find small areas of disease that, if untreated, could result in tumor relapse. We have developed 18F-fluorodopamine (18F-DA) for PET imaging in our patients with neuroblastoma.
The primary objective is to explore the safety of 18F-DA in patients with known or suspected neuroblastoma or pheochromocytoma. The secondary objectives are to evaluate the biodistribution of 18F-DA in patients with neuroblastoma and compare the biodistribution of 18F-DA with the biodistribution of 123I-mIBG.
Patients receive an intravenous injection of a small (tracer) dose of 18F-DA. Approximately 1 hour later, patients undergo PET scanning of the entire body to evaluate the localization of the tracer.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known or suspected neuroblastoma or pheochromocytoma are eligible. 18F-DA PET/CT scanning will not be the initial imaging study in a newly diagnosed patient.
- •Patients with positive findings on prior imaging within the past 4 weeks are eligible.
- •Prior therapy is allowed.
- •Patients > 1 year of age, under the care of a SJCRH physician.
- •Patients of both genders, and all ethnic groups, under the care of a SJCRH physician.
- •Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
- •Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.
- •Patients may undergo a repeat study one or more years following the initial FLOPET scan.
排除标准
- •Inability or unwillingness of patient, parent, or guardian to consent.
- •Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation. Patients should not become pregnant within one month of completion of 18F-DA PET scan.
- •Use of medications known to interfere with 123I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48 hours, and labetalol which needs to be discontinued for 6 weeks).
- •Patients less than 3 years of age who require a total length of anesthesia time greater than 3 hours (for the FLOPET scan in conjunction with another clinical procedure requiring sedation) will be excluded from the study.
研究组 & 干预措施
Injection of 18F-DA
18F-DA will be injected into a vein in the arm or leg, or via central venous access line.
干预措施: 18F-DA (Drug)
结局指标
主要结局
Adverse event rate
时间窗: up to 2 days following injection of the radiotracer 18F-DA.
The adverse events will be recorded and monitored up to two days after the injection of radiotracer 18F-DA. The 95% CI for the adverse event rate will be calculated and reported. If one adverse event grade 2 or above, attributable to study drug, the study will be stopped until completion of IRB review and a decision about whether the study should be modified or closed.
次要结局
- max SUV from 18F-DA and 123I-mIBG PET(up to half year following injection of the radiotracer 18F-DA.)
- The frequency of localization of 18F-DA in different organs.(up to half year following injection of the radiotracer 18F-DA.)