Studies of Methionine-PET and PBR28-PET in Brain Metastases to Differentiate Tumor Recurrence and Radiation Necrosis Following Stereotactic Radiosurgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Regrowing Tumor Rate from Radiation Effect
研究概览
简要总结
The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport and microglial activation to improve the differentiation of tumor recurrence and radiation necrosis in patients with brain metastases after treatment with stereotactic radiosurgery (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET (fluorodeoxyglucose).
详细描述
The investigators hypothesize that by using two different PET tracers, one sensitive to tumor metabolic activity, and one sensitive to inflammatory processes, investigators can separately identify metabolically active tumor from radiation necrosis related inflammation. This can be accomplished with quantitative assessments of tracer uptake using kinetic modeling techniques, as well as by high-resolution imaging to assess the distribution of tracer uptake in the tumor region. All participants in the study will have the receive the same diagnostic tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years with brain metastases from melanoma or non-small cell lung cancer
- •Patients must have had SRS and regrowth in at least one lesion > 0.5 cm in greatest dimension and fall into one of two categories: a) patient is deemed clinically appropriate for surgical intervention (biopsy or craniotomy) OR b) patient is asymptomatic and has a life expectancy of > 6 months so that serial follow-up imaging is appropriate
- •Willingness to participate in imaging studies
- •Able to give informed consent
排除标准
- •Subjects with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
- •Subjects who are pregnant or currently breastfeeding
- •Women of child-bearing age who are sexually active, unless they agree to two forms of contraception, and have a negative urine pregnancy test at screening and on the days of the PET imaging
- •Patients unable to undergo MRI with gadolinium-based contrast for standard clinical reasons which include:
- •Cardiac pacemaker, aneurysm clip, cochlear implants, Intra Uterine Device (IUD), shrapnel, neurostimulators, defibrillator, artificial heart valve, or history of metal fragments in eyes.
- •Pregnancy
- •Body size too large for closed MRI
- •Known hepatic fibrosis.
- •Claustrophobia
- •Contraindication to MR contrast agents: eGFR (epidermal growth factor receptor) < 30 by the Cockcroft- Gault formula if > 60 years old or with chronic renal disease
- •Anaphylactic allergy to gadolinium
结局指标
主要结局
Change in Regrowing Tumor Rate from Radiation Effect
时间窗: 6 months
次要结局
未报告次要终点