A Centralized Protocol Evaluating the Safety and Clinical Impact of Amino Acid Pet for Brain Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Impact of 18F-DOPA PET/CT on clinical management
研究概览
简要总结
This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether the addition of amino acid PET to standard of care imaging impacts clinical management of brain tumor patients in over 50% of cases.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of amino acid PET for brain tumor patients in response to Food and Drug Administration (FDA) guidance that such data is needed to support a potential New Drug Application (NDA) for fluorodopa F 18 (18F-DOPA).
II. To assess the rate of identification of tumor outside of standard magnetic resonance imaging (MRI) imaging.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Diagnosis of a brain tumor
- •Indication for amino acid PET imaging, including presurgical evaluation, radiation planning, MR imaging indeterminate for progression versus treatment effect, or clinical need for enhanced monitoring
- •Ability to give appropriate consent or have an appropriate representative available to do so
排除标准
- •Patient is unable to undergo PET imaging
- •Persons who are pregnant or nursing
研究组 & 干预措施
Diagnostic (18F-DOPA)
Patients receive 18F-DOPA IV and undergo PET/CT over 30 minutes on day 1.
干预措施: Computed Tomography (Procedure)
Diagnostic (18F-DOPA)
Patients receive 18F-DOPA IV and undergo PET/CT over 30 minutes on day 1.
干预措施: Fluorodopa F 18 (Drug)
Diagnostic (18F-DOPA)
Patients receive 18F-DOPA IV and undergo PET/CT over 30 minutes on day 1.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Impact of 18F-DOPA PET/CT on clinical management
时间窗: 3 days post-PET scan, up to 64 days
Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant has received fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)/computed tomography (CT). The survey consists of 4 questions, 1 multiple choice (what will PET scan be used for); 2 yes/no and one open-ended question related with how PET scan did or did not make a clinically meaningful impact in the management of patient care.
次要结局
- Incidence of adverse events(3 days post-PET scan, up to 64 days)
- Rate of identification of tumor outside of standard magnetic resonance imaging (MRI)(3 days post-PET scan, up to 64 days)