Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the standardized uptake value (SUV) parameters
研究概览
简要总结
The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 years
- •Performance status, Eastern Cooperative Oncology Group 0-2
- •Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
- •Plan for SSRS per the treating team
- •For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
- •For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography/computerized tomography
排除标准
- •Prior anaphylactic reaction to 18F-fluciclovine
- •Evidence of leptomeningeal disease
- •Prior whole-brain radiation therapy
- •Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- •Females pregnant at the expected time of 18F-fluciclovine administration
- •Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed
- •Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
研究组 & 干预措施
PET/CT, MRI
In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.
干预措施: 18F fluciclovine (Drug)
结局指标
主要结局
Change in the standardized uptake value (SUV) parameters
时间窗: through study completion, an average of 1 year
To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.
Change in sensitivity for MRI
时间窗: through study completion, an average of 1 year
To calculate the sensitivity of pre-treatment contrast-enhanced MRI.
Change in sensitivity for PET/CT
时间窗: through study completion, an average of 1 year
Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases \>2 cm treated with SSRS.
次要结局
- Compare change of SUV metrics of contrast-enhanced MRI(baseline)
- Compare change of SUV metrics of 18F-fluciclovine PET(baseline)