[11C]Acetate PET in Patients With Glioma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Visual differences from normal brain in patients with grades 2, 3 or 4 gliomas
研究概览
简要总结
At each point that the patient will have [11C]-Acetate PET study, this will be compared with standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide (chemotherapy)
Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will be analyzed qualitatively by visual assessment, quantitatively using a standard uptake value (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by compartmental modeling of dynamic data.
详细描述
- [11C]Acetate Administration [11C]Acetate will be administered in the Clinical PET Facility located on the 2nd floor of the Clements Imaging Building at UT Southwestern. Upon arrival, the patient will have an opportunity to have questions answered regarding the procedure. The patient will have one intravenous line placed prior to [11C]Acetate administration. The patient will receive the low-dose CT portion of a PET/CT scan, after which [11C]Acetate will be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30 mCi) and followed by a saline flush. The injection and imaging procedure will be terminated in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering physician will stay with the patient for at least 15 min after injection and will remain in the Clinical PET Facility through the duration of the imaging procedure. All adverse events occurring post [11C]Acetate infusion will be recorded within a 24-hour period. The adverse events to be specifically monitored during the infusion include localized discomfort at the IV injection site, pain, respiratory difficulties, flushing, dizziness, pruritus/rash, and any other symptoms that could be secondary to an anaphylactic reaction. The subject will be instructed to report any subjective symptoms or sensory changes noted.
Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the patient on the scanner and securing the head in a head restraint, a low dose CT of the brain will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and attenuation correction and it is not considered to be a diagnostic quality CT. Following the completion of the CT, the [11C]Acetate will be administered as described in Section VI.F.3.b.
A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes. From the list mode data a flow image series will be constructed as follows:
- 12 frames x 10 seconds each (out to 2 minutes post-injection)
- then 6 frames x 30 seconds each
- then 1 frame x 60 seconds each
A second series will be -reconstructed to demonstrate dynamic brain regional metabolism as follows:
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
- •Male or female, age 18 and older, of any ethnic group
- •Spanish-speaking patients will be eligible
- •Histological diagnosis of glioma or
- •Brain MR imaging suggestive of a glioma or 2HG > 2mM by MR spectroscopy in patients who have not had a surgical procedure to establish the diagnosis.
- •Karnofsky Performance status > 70%
- •Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
- •Patient able and willing to provide informed consent
排除标准
- •Patient or legal parent/guardian unable to provide informed consent
- •Psychiatric or addictive disorders that preclude obtaining informed consent
- •Karnofsky Performance status < 70%
- •NYHA class III and IV congestive heart failure
- •Unstable angina
- •Pregnant or lactating women
- •Women of childbearing potential who refuse a pregnancy test
结局指标
主要结局
Visual differences from normal brain in patients with grades 2, 3 or 4 gliomas
时间窗: Every 3 months for 24 months
Visual assessment and SUV with standard clinical MR imaging assessment.using T2/FLAIR and gadolinium enhancement.
次要结局
- Decrease in [11C]Acetate uptake following treatment of grade 2 glioma(Every 3 months for 24 months)
- Decrease in [11C]-acetate uptake following treatment of grade 3 and 4 glioma(Every 3 months for 24 months)
- Change in [11C]-acetate uptake following treatment at time of progression in grade 3 and 4 gliomas(Every 3 months for 24 months)