Imaging Apoptosis for Lymphoma Treatment Response
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Whole body effective dose (in rems) of a 5 mCi injection of 18F-FAT (Cohort 1 only)
研究概览
简要总结
Apoptosis is a specific form of cell death that leads to clearance of dead cells without causing inflammation or injury to normal adjacent tissues. Targeted cancer therapeutics that target this pathway for tumor cell death induction are in development, but few specific biomarkers of apoptosis are available to assess treatment response. Apoptosis also occurs in response to standard anthracycline or combination therapies such as rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP), rituximab, etoposide, phosphate, prednisone, vincristine sulfacte, cyclophosphamide, and doxorubicin hydrocholoride (R-EPOCH) used to treat many different histopathological types of lymphoma including Hodgkin and non- Hodgkin lymphoma such as diffuse large B-cell lymphoma (DLBCL), Burkitts lymphoma, primary mediastinal B-cell lymphoma and double hit DLBCL. Caspase-3 activation occurs as a result of apoptosis and may be a specific marker of apoptosis. Therefore, this study will assess whether 18F-FluorApoTrace (18F-FAT), a caspase-3 targeted tracer, has a reasonable dosimetry profile and can be used to detect apoptosis in patients with lymphoma being treated with standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 = Healthy Volunteers
-
Healthy volunteers (N=6, three male, three female) will be recruited to undergo a single 18F-FAT PET/CT imaging session for radiation dosimetry estimates.
-
18F-FAT administration followed by body imaging at 3 time points
-
0-60 min = multiple quick body scans
-
120 min post injection = body scan
-
240 min post injection = body scan
干预措施: 18F-FluorApoTrace (Drug)
Cohort 2a: Newly Diagnosed DLBCL patients being treated with R-CHOP
-N= 6 : 18F-FAT imaging session at baseline and Day 2-4 following Cycle 1 standard of care therapy.
干预措施: 18F-FluorApoTrace (Drug)
Cohort 2b: Newly Diagnosed DLBCL patients being treated with R-CHOP
-N=9: 18F-FAT imaging session at baseline and best time point determined from Cohort 2a (2 days post Cycle 1 standard of care therapy)
干预措施: 18F-FluorApoTrace (Drug)
结局指标
主要结局
Whole body effective dose (in rems) of a 5 mCi injection of 18F-FAT (Cohort 1 only)
时间窗: Day 1
-The time activity curves will be created using all the scans obtained and integrated to determine organ residence times. This data, plus the counts and volumes from urine collection(s) after tracer injection, will then be used to calculate the dosimetry using OLINDA/EXM v1.1. The calculated residence times will be used with the program OLINDA/EXM for 18F and using the adult human (adult female or male) model to calculate the whole body effective dose.
Change in mean standard uptake value (SUV) (Cohort 2 only)
时间窗: Through completion of early interim treatment monitoring scan (estimated to be 14 days)
-30 minutes and 60-90 minutes post pre-treatment baseline monitoring scan and 30 minutes and 60-90 minutes post early interim treatment monitoring scan
Radiation doses (rems) to critical organs (Cohort 1 only)
时间窗: Day 1
The time activity curves will be created using all the scans obtained and integrated to determine organ residence times. This data, plus the counts and volumes from urine collection(s) after tracer injection, will then be used to calculate the dosimetry using OLINDA/EXM v1.1. The calculated residence times will be used with the program OLINDA/EXM for 18F and using the adult human (adult female or male) model to calculate the individual organ radiation dose.
Change in maximum standard uptake value (SUV) (Cohort 2 only)
时间窗: Through completion of early interim treatment monitoring scan (estimated to be 14 days)
-30 minutes and 6-90 minutes post pre-treatment baseline monitoring scan and 30 minutes and 60-90 minutes post early interim treatment monitoring scan
次要结局
- Distribution volume ratio (DVR) (Cohort 2 only)(Through completion of early interim treatment monitoring scan (estimated to be 14 days))
- Change in percent positive caspase-3 staining (Cohort 2 only)(Baseline and post-treatment (estimated to be 14 days))