Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Biopsy Correlation
研究概览
简要总结
This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly identify recurrent tumor versus post treatment effects (radionecrosis) in patients with previously treated high grade brain gliomas.
详细描述
The study is designed to investigate the effectiveness of Carbon Acetate PET/CT (AC PET)in terms of its ability to distinguish between radionecrosis/pseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors.
Eligible patients with biopsy proven high grade gliomas (WHO grades 3 and 4) status-post prior cranial irradiation for this tumor; age 18 to 70; ECOG/Zubrod of 0-2, no other contraindications to trial entry, and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology (not biopsied) will be treated with at least two weeks of steroidal therapy.
Responders to steroidal therapy will be classified as either pseudo-progression (if asymptomatic) or radionecrosis (if symptomatic). Non-responders (those who do not respond clinically, radiographically, or both) will be referred for an FDG PET/CT and initial AC PET/CT within 3 weeks, and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment (in the same operative setting) within 3 weeks of AC PET/CT.
Specific Goals/Questions:
- What is the yield (sensitivity, accuracy, positive and negative predictive value) of state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population?
- How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET) and with that of MRI?
- Evaluate the optimal timing for post injection 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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-70
- •Pathologically confirmed World Health Organization (WHO) grade 3 or 4 glioma
- •ECOG/Zubrod 0-2
- •Prior external beam radiotherapy to 59.4-60 Gray by 1.8-2 Gy fractions
- •Post-radiotherapy contrast-enhanced cranial MRI obtained at least 6 weeks after the completion of external beam radiotherapy shows enhancing anomaly (recurrent/progressive tumor versus pseudo-progression versus radionecrosis)
- •Patient completed at least a two week course of palliative steroid therapy for this enhancing anomaly
- •No prior designated therapy other than steroids for presumed radionecrosis or recurrent tumor
- •Patient with no clinical and/or radiological response to steroid therapy
- •Patient eligible for stereotactic brain biopsy
- •Patient eligible for focal laser therapy
排除标准
- •Patients under the age of 18 years
- •Claustrophobic patients
研究组 & 干预措施
Sodium Acetate C11 PET/CT Imaging
干预措施: Sodium Acetate C11 PET/CT Imaging (Drug)
结局指标
主要结局
Biopsy Correlation
时间窗: 3 weeks from AC PET Imaging
AC PET imaging results will be correlated with tissue biopsy results
次要结局
- SUV (Standardized Uptake Value)(Day 1 - Assess at time of PET imaging)
研究者
Fabio Almeida MD
Medical Director/PI
Phoenix Molecular Imaging
