Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Tumor volume
研究概览
简要总结
This early phase I trial studies how well F18 fluciclovine positron emission tomography (PET)/computed tomography (CT) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. Radioactive imaging agents, such as F18 fluciclovine, used during PET/CT scan may help measure tumor size compared to standard of care magnetic resonance imaging (MRI) contrast agents in patients receiving radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To compare fluciclovine F18 (F18 fluciclovine) PET CT for tumor volume assessment compared to T2 fluid attenuated inversion recovery (FLAIR) and T1 post contrast magnetic resonance (MR) brain imaging.
SECONDARY OBJECTIVES:
I. To assess changes in F18 fluciclovine defined disease with surgery and radiation.
II. To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity.
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
- •Patient is a candidate for brain tumor resection and radiation with lesion suspected to be or previously biopsy proven to be a glioblastoma.
- •Patient is able to understand and give consent to participation in the study.
排除标准
- •Pregnant.
- •Known allergy to gadolinium-based contrast agents or F18 fluciclovine.
- •Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m^
- •Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:
- •Electronically, magnetically, and mechanically activated implants
- •Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
- •Metallic splinters in the eye
- •Ferromagnetic hemostatic clips in the central nervous system (CNS) or body
- •Cochlear implants
- •Other pacemakers, e.g., for the carotid sinus
- •Insulin pumps and nerve stimulators
- •Non-MR safe lead wires
- •Prosthetic heart valves (if dehiscence is suspected)
- •Non-ferromagnetic stapedial implants
- •Pregnancy
- •Claustrophobia that does not readily respond to oral medication.
结局指标
主要结局
Tumor volume
时间窗: Up to 6 months
Will be assessed with fluciclovine F18 (F18 fluciclovine) positron emission tomography (PET) computed tomography (CT). The three volumes measured (amino acid hypermetabolic volume \[AHV\], T2 fluid attenuated inversion recovery \[FLAIR\] and T1 contrast \[T1C\]) will be compared to each other for each patient, and plotted as boxplots, both raw (as mL) and as normalized values (to the T1C volume) to facilitate comparisons between patients.
次要结局
- Post-radiation enhancing brain tissue(Up to 6 months)
- Changes in F18 fluciclovine defined disease with surgery and radiation(Baseline up to 6 months)