JPRN-jRCTs031180302已完成2 期
Clinical study to evaluate the usefulness of 18F-FBPA-PET for patient selection and expanding indication for BNCT
Takai Yoshihiro0 个研究点目标入组 20 人开始时间: 2019年3月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
In the 16 evaluable lesions, the SUVmax of 18F-FBPA was 4.5 +-1.1 using the cervical FOV and 3.4 +- 0.8 using the trunk FOV. The tumor-to-normal tissue ratio (TNR) was 3.6 +- 0.8 for the cervical FOV. The Tumor-to-blood ratio by ascending aorta (TBRAAo) was 3.0 +- 0.8, and TBR by left ventricle (TBRLV) was 2.8 +- 0.8. The correlation coefficient for SUVmax between 18F-FBPA-PET and 11C-MET-PET was 0.32; that for TNR was 0.72. The correlation to 18F-FDG-PET was 0.13 at cervical FOV and 0.33 at trunk FOV.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1. Patient has voluntarily signed the informed consent
- •2. Patients' age 20=<,<80
- •3. Patients have histopathologically proven malignant tumors and tumor lesions more than 1cm in diameter on CT or MRI.
- •4. Patients who falls under any of the following categories:
- •A) Patients newly diagnosed with malignant tumors have not received anti-cancer therapy yet
- •B) Patients newly diagnosed with tumor recurrence and progression by CT or MRI have not received newly anti-cancer therapy yet
- •5 Patients who have not previous history of radiotherapy or who have radiotherapy more than 3 months before.
- •6 Patients with ECOG PS score 0-2
- •7 Patients who falls under any of the following categories:
- •A) Patients who can be taken 2 PET examinations, 11C-MET-PET and 18F-FBPA-PET within 3weeks after when 18F-FDG-PET study was conducted.
- •B) Patients who can be taken 18F-FDG-PET and 11C-MET-PET on the same day, in addition, can be taken F-FBPA-PET within 2 weeks of date of those examinations.
- •8. Patients who can be held in supine position during PET examinations
- •9. Patients with stable main organ functions such as liver or kidney on hematologic test for the past 6 months
- •WBC >= 3,000/mm3 and <= 12,000/mm3
- •ANC >= 1,500/mm3
- •Platelets >= 100,000/mm3
- •AST(GOT) =< 2.5 x the ULN for the reference lab
- •ALT(GPT) =< 2.5 x the ULN for the reference lab
- •Creatinine =<1.5mg/dL
- •10. Patients have no clinically significant abnormalities in 12-lead ECG for the past 6 months.
排除标准
- •1. To provide therapy evaluation
- •2. Patients with significant complications
- •3. Patients with phenylketonuria
- •4. Patients who were enrolled in this clinical study or BNCT related study
- •within 3 months after the initial informed consent or who are participating and will participate in other clinical study
- •5. Patients who are pregnancy and want to become pregnant and male
- •6. Patients with complications of mental disease or psychological symptom
- •can't be participated in this clinical study or are taking antipsychotics
- •7. Patients with poorly controlled epilepsy
- •8. Patients whom an attending physician determined ineligible
研究者
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