18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in SUVmean
研究概览
简要总结
This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.
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
- •Diagnosis of cancer with radiographic finding of brain metastasis
- •Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
- •Planned treatment with SRS as per the treating physician team
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET
排除标准
- •Prior anaphylactic reaction to 18F-fluciclovine
- •Radiographic evidence of leptomeningeal disease
- •Prior whole-brain radiation therapy
- •Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- •Pregnant or positive serum pregnancy test within 14 days of registration
- •Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 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 and/or preclude informed consent*
- •A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.
研究组 & 干预措施
18F-Fluciclovine PET Imaging
Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.
干预措施: 18F fluciclovine (Drug)
结局指标
主要结局
Change in SUVmean
时间窗: 8 weeks
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Change in SUVmax
时间窗: 8 weeks
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Change in Standardized Uptake Value (SUV)-peak
时间窗: 8 weeks
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
次要结局
- Tumor Control(12 months)