FBY PET/CT in Patients With Brain Tumors
关键词
抽象
描述
FBY is a new PET tracer derived from tyrosine, with the carboxyl group replaced by boron trifluoride, and is transferred across cell membrane through LAT-1. LAT-1 is a sodium independent amino acid transporter and is highly expressed in tumor cells. Considering the significant role in cancer development as well as in nutrient delivery, FBY could be a promising PET tracer to reflect altered metabolism in tumors.
This study aim to observe the safety of FBY, and investigate the diagnostic, prognostic, predictive performance of FBY in the patient with suspected brain tumors. Patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition, explaining the benefits and risks of clinical trials, clarifying the patient's willingness to include the clinical trial, and signing informed consent. The cohort number, FBY administrative dose, imaging protocols are decided based on the investigators' preliminary data. The diagnosis and post-examination treatment are based on the recommended guideline, combined with the subject's own situation for standardized diagnosis and treatment.
日期
| 最后验证: | 05/31/2019 |
| 首次提交: | 06/05/2019 |
| 提交的预估入学人数: | 06/06/2019 |
| 首次发布: | 06/09/2019 |
| 上次提交的更新: | 06/06/2019 |
| 最近更新发布: | 06/09/2019 |
| 实际学习开始日期: | 12/31/2018 |
| 预计主要完成日期: | 12/30/2021 |
| 预计完成日期: | 12/30/2021 |
状况或疾病
干预/治疗
Diagnostic Test: FBY-PET Group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: FBY-PET Group | Diagnostic Test: FBY-PET Group A single dose of 0.15 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 1. Have suspected diagnosis of brain tumors, based on clinical performance and MRI results. - 2. Meet the indications for PET examination, show a clear indication and no contraindications; - 3. Have a performance status of score >80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation; - 4 Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; - 5. Be > 18 years of age on day of signing informed consent. - 6. Be willing and able to understand the research content and provide written informed consent/assent for the trial. Exclusion Criteria: - 1. Have a history of imaging agent allergies; - 2. Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination; - 3. Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; - 4. Unable to adhere strictly to protocol requirements. |
结果
主要结果指标
1. standardized uptake value (SUV) for FBY [1 week.]
次要成果指标
1. Adverse events [1 week.]
