Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Pancreatic Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The investigators plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16 weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to participate in a clinical trial that contains PARP inhibitor therapy and are anticipated to receive this treatment or (3) will receive PARP inhibitor therapy as part of their clinical care.
A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to the start of treatment with a PARP inhibitor.
PET/CT imaging will be used to evaluate PARP-1 expression in sites of pancreatic cancer using the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria.
Patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of [18F]FTT. This procedure will be followed by a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of approximately 10 mCi (approximate range for most studies is anticipated to be 8-12 mCi) of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of pancreatic cancer, which will be compared with PARP-1 expression in tissue, when available.
All 30 evaluable patients are expected to start PARP inhibitor therapy following the [18F]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 24 patients (80%) will also undergo a second (optional) scan that will be performed approximately 3 weeks (± 1 week) after therapy has started. The second scan is obtained to evaluate whether the PARP inhibitor therapy decreases [18F]FTT uptake, which would suggest PARP blocking by the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Participants will be ≥ 18 years of age.
- •Histologically proven pancreatic adenocarcinoma. .
- •Deemed to have achieved stability following ≥16 weeks of platinum based therapy, in the opinion of an investigator
- •Considered a candidate for PARP inhibitor therapy, with or without additional agents, either on a clinical trial or as part of clinical care.
- •Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
排除标准
- •Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
- •Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- •Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
研究组 & 干预措施
[18F]FluorThanatrace ([18F]FTT)
1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one also known as [18F]FluorThanatrace or [18F]FTT is a positron emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo inhibition of the PARP-1 nuclear enzyme with positron emission tomography (PET/CT).
干预措施: [18F]FluorThanatrace ([18F]FTT) (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 3 years
次要结局
未报告次要终点