Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Compare pre-therapy and post-therapy voxel-based dosimetry estimates
研究概览
简要总结
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
- Complete two phases involving 6 visits
- Undergo additional research PET/CT, and possibly SPECT/CT scans
详细描述
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
排除标准
- •Unable to lie flat during or tolerate PET/CT or SPECT/CT
- •Known incompatibility to CT. SPECT, or PET scans
- •Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
研究组 & 干预措施
Participants treated with Lutathera
干预措施: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) (Device)
Participants treated with Lutathera
干预措施: Photon Emission Tomography / CT (PET/CT) (Device)
Participants treated with Lutathera
干预措施: 64Cu-Dotatate (Drug)
Participants treated with Lutathera
干预措施: 177Lu-Dotatate (Drug)
结局指标
主要结局
Compare pre-therapy and post-therapy voxel-based dosimetry estimates
时间窗: Baseline and 120 hours post-dose
Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated.
次要结局
- Absorbed radiation doses(1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose)
- Absorbed radiation doses of 64Cu-DOTATATE(1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose)
- Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE(Baseline and 120 hours post-dose)