[18F]FTT Positron Emission Tomography/Computed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma
2026年8月12日 更新者：University of Washington
Imaging PARP Expression in Cholangiocarcinoma
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
22
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Angela Castellanos Rodriguez, MD, MSc
- 电话号码：206-606-6777
- 邮箱：acastell@uw.edu
学习地点
-
-
Washington
-
Seattle、Washington、美国、98109
- Fred Hutch/University of Washington Cancer Consortium
-
接触：
- Angela Castellanos Rodriguez, MD, MSc
- 电话号码：206-606-6777
- 邮箱：acastell@uw.edu
-
首席研究员：
- Angela Castellanos Rodriguez, MD, MSc
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
进行核磁共振
其他名称：
接受PET/CT
其他名称：
鉴于IV
其他名称：
接受 PET/CT 和/或 CT
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relationship between standardized uptake value maximum (SUVmax) and overall response rate
大体时间：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.
|
At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relationship between standardized uptake value mean (SUVmean) and overall response rate
大体时间：At baseline and 24 weeks after starting GCD
|
Will measure baseline SUVmean from an ROI placed on the tumor lesion of interest using a 40% threshold.
Treatment response will be defined by RECIST 1.1 criteria at 24 ± 2 weeks following GCD treatment.
Association between baseline SUVmean and treatment response will be evaluated using Wilcoxon rank-sum test.
Logistic regression will be used to quantify the magnitude and direction of association between baseline SUVmean and response.
Results will be summarized using odds ratios with 95% confidence intervals, and boxplot to illustrate the distribution of baseline SUVmean between responders and non-responders.
|
At baseline and 24 weeks after starting GCD
|
|
Change in SUVmax and response
大体时间：Baseline to 12 weeks after starting GCD
|
Will calculate the change of SUVmax from baseline to 12 ± 2 weeks after starting GCD.
Due to the limited sample size, will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference in change between responders and non-responders.
Effect sizes will be summarized using the median difference (Hodges-Lehmann estimator) in change between groups with 95% confidence intervals.
|
Baseline to 12 weeks after starting GCD
|
|
Change in SUVmean and response
大体时间：Baseline to 12 weeks after starting GCD
|
Will calculate the change of SUVmean from baseline to 12 ± 2 weeks after starting GCD.
Due to the limited sample size, will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference in change between responders and non-responders.
Effect sizes will be summarized using the median difference (Hodges-Lehmann estimator) in change between groups with 95% confidence intervals.
|
Baseline to 12 weeks after starting GCD
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Angela Castellanos Rodriguez, MD, MSc、Fred Hutch/University of Washington Cancer Consortium
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2028年7月1日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年6月22日
首先提交符合 QC 标准的
2026年6月22日
首次发布 (实际的)
2026年6月29日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- RG1126474
- NCI-2026-03509 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- FHIRB0021301 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.