Imaging PARP Expression in Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Relationship between standardized uptake value maximum (SUVmax) and overall response rate
研究概览
简要总结
This phase II trial studies whether [18F]FTT can be used with positron emission tomography (PET)/computed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma. PET/CT is an imaging technique that utilizes PET and CT in a single machine. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, [18F]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient's body. [18F]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1). Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET/CT. Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment. Researchers hope that by using [18F]FTT with PET/CT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.
详细描述
OUTLINE:
Patients receive [18F]FTT intravenously (IV) and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or magnetic resonance imaging (MRI) throughout the study.
After completion of study intervention, patients are followed up at week 24 and then up to 6 months after completing GCD treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patient must have histologically confirmed cholangiocarcinoma
- •Patient must be newly diagnosed and have not yet been treated
- •Patient planned to receive GCD per standard-of-care
- •Patient must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or MRI) per RECIST 1.1
- •Age ≥ 18 years
- •For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to [18F]FTT PET imaging
- •Men and women of reproductive potential need to agree to employ acceptable forms of contraception throughout their participation in the study that meet requirements for GCD treatment per standard of care
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures
- •Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures
排除标准
- •Pregnant or breastfeeding women
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Diagnostic ([18F]FTT PET/CT)
Patients receive [18F]FTT IV and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study.
干预措施: Computed Tomography (Procedure)
Diagnostic ([18F]FTT PET/CT)
Patients receive [18F]FTT IV and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study.
干预措施: Fluorine F 18 Fluorthanatrace (Radiation)
Diagnostic ([18F]FTT PET/CT)
Patients receive [18F]FTT IV and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic ([18F]FTT PET/CT)
Patients receive [18F]FTT IV and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Relationship between standardized uptake value maximum (SUVmax) and overall response rate
时间窗: At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD)
Baseline SUVmax will be extracted from a region of interest (ROI) placed on the tumor lesion of interest using a 40% threshold. Will assess overall response rate at 24 ± 2 weeks after starting GCD by using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Response will be analyzed as a binary outcome. Differences in baseline SUVmax between responders and non-responders will be evaluated using the Wilcoxon rank-sum test. Logistic regression models will be used to estimate the direction and magnitude of association, with response as the dependent variable and SUVmax as the predictor. Odds ratios and 95% confidence intervals will be reported. Analysis will focus on estimation of effect sizes and the direction and magnitude of associations of the primary endpoints, overall response rate and SUVmax of the most avid lesion, rather than formal hypothesis testing alone. Boxplots will be used to visualize the distribution of SUVmax by responders group.
次要结局
- Relationship between standardized uptake value mean (SUVmean) and overall response rate(At baseline and 24 weeks after starting GCD)
- Change in SUVmax and response(Baseline to 12 weeks after starting GCD)
- Change in SUVmean and response(Baseline to 12 weeks after starting GCD)