Differentiating Brain Tumor Recurrence From Treatment-Induced Necrosis Using 18F-Fluciclovine (Anti-18f-facbc) PET and Multiparametric MR Imaging
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 18F-Fluciclovine
研究概览
简要总结
The purpose of the study is to investigate the use of the investigational agent Axumin (fluciclovine-F18) with PET/CT imaging in combination with standard MR imaging to detect remaining or recurrent brain tumor.
详细描述
Methods:
Patients with recurrent enhancing mass on MRI in the side of a diagnosed and treated high grade glioma or metastatic brain tumor and consenting to study protocol will undergo 18F-Fluciclovine PET/CT imaging once prior to surgery for brain tumor recurrence. Surgery for recurrent brain tumor will follow standard of care treatment that includes either biopsy of the region or interest or as complete as possible tumor resection followed by histopathological analysis. Outcome evaluation will be analysis of tumor histology and imaging results, comparison of MRI, MRSI, and 18F-Fluciclovine imaging and relationship of imaging findings with histopathology and anatomical location of recurrent tumor.
Study Objectives
- In this study, we will investigate the potential of 18F-fluciclovine to aid the visualization of residual or recurrent gliomas as depicted by 18F-Fluciclovine PET imaging compared to standard MRI sequences [T1 weighted imaging (T1WI) with contrast, diffusion weighted imaging (DWI), perfusion weighted imaging (PWI), T2 weighted fluid attenuated inversion recovery (T2 FLAIR)] using 3D image fusion.
- To assess the residual or recurrent of glioma as depicted by 3D short echo time MR spectroscopic imaging (MRSI) using metabolic tumor markers such as elevated choline, myo-Inositol and lipids and reduced N-acetyl-aspartate (NAA) compared to standard MRI sequences (T1WI with contrast, PWI, T2 FLAIR) using 3D image fusion before neurosurgical intervention.
- To spatially register the residual or recurrent glioma as depicted by 18F-Fluciclovine PET imaging with MR T1WI, DWI, PWI, and 3D MRSI to a) quantitate (SUVmax, SUVmean, ADCmean, rCBV, Cho, NAA, lipids, Cho/Cr, Cho/NAA) and correlate areas of PET+, T1WI+ and MRSI+ areas and b) characterize different metabolic profiles measured with MRSI in areas of glioma infiltration depicted by PET imaging and MRI.
- Biopsy and pathology confirmation of tumor vs treatment-induced necrosis in spatially registered areas of interest will be performed.
Safety analysis Although 18F-Axumin™ is an FDA approved PET imaging agent for biological recurrent prostate cancer with extensive safety and toxicity data already documented, all patients will be monitored closely for adverse reactions after administration.
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
- •Patients with prior histological confirmation of glioma or metastatic brain tumor evaluated for tumor recurrence or radiation changes after initial treatment of surgery, external beam radiation and / or chemotherapy with temozolamide.
- •Male and female
- •Ages 18 or greater
排除标准
- •Patient diagnosis with glioma or metastatic brain tumor but prior to surgery, external beam radiation and /or chemotherapy
- •Women who were pregnant, breast feeding, or possibly pregnant.
- •Patients with hepatic or renal dysfunction.
- •Patients with MRI contraindications (i.e. pacemakers, non-MR compatible devices).
- •Patients with a history of drug hypersensitivity to 18F-Fluciclovine.
研究组 & 干预措施
Axumin (fluciclovine-F18) PET/CT scan
Axumin (fluciclovine-F18) PET/CT scan to evaluate possible glioma recurrence to help differentiate scar (fake recurrence) from true tumor recurrence
干预措施: PET/CT with F-Fluciclovine (Axumin) (Drug)
结局指标
主要结局
18F-Fluciclovine
时间窗: 2 years
Investigate the potential of 18F-fluciclovine to aid the visualization of residual or recurrent gliomas as depicted by 18F-Fluciclovine PET imaging compared to standard MRI sequences \[T1 weighted imaging (T1WI) with contrast, diffusion weighted imaging (DWI), perfusion weighted imaging (PWI), T2 weighted fluid attenuated inversion recovery (T2 FLAIR)\] using 3D image fusion.
3D short echo time MR spectroscopic imaging (MRSI)
时间窗: 2 years
Using metabolic tumor markers such as elevated choline, myo-Inositol and lipids and reduced N-acetyl-aspartate (NAA) compared to standard MRI sequences (T1WI with contrast, PWI, T2 FLAIR) using 3D image fusion before neurosurgical intervention.
18F-Fluciclovine PET imaging with MR T1WI, DWI, PWI, and 3D MRSI
时间窗: 2 years
Quantitate (SUVmax, SUVmean, ADCmean, rCBV, Cho, NAA, lipids, Cho/Cr, Cho/NAA) and correlate areas of PET+, T1WI+ and MRSI+ areas and b) characterize different metabolic profiles measured with MRSI in areas of glioma infiltration depicted by PET imaging and MRI.
Biopsy and pathology
时间窗: 2 years
Confirmation of tumor vs treatment-induced necrosis in spatially registered areas of interest will be performed.
次要结局
未报告次要终点