18F-Clofarabine (CFA) as a PET Imaging Agent to Measure Deoxycytidine Kinase (DCK) Activity in Metastatic Cancer, as a Candidate Predictive Biomarker for Response to DCK-dependent Drugs Such as Gemcitabine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Evaluate CFA as a PET imaging agent
研究概览
简要总结
The purpose of this study is to evaluate whether a new type of imaging study, called 18F-Clofarabine (CFA) PET/CT, can be used to image cancer pyrimidine metabolism in participants.
PET (positron emission tomography) imaging is a way of looking at cancers that can reveal cancer metabolism. Presently, however, there are no imaging agents in routine use to look at an aspect of cancer metabolism (pyrimidine metabolism) that dictates whether certain cancer drugs, e.g., gemcitabine, are likely to be taken into the cancer cells. This clinical trial will be testing whether 18F-Clofarabine (CFA) could be an imaging agent to measure this aspect of cancer metabolism.
详细描述
The participants will receive a CFA injection into a vein in their arm. The imaging drug is attracted to and taken into certain cells in the body, including cancer cells. 18F-Clofarabine (CFA) is experimental because it is not approved by the Food and Drug Administration (FDA).
The participants will be observed for side effects, and about 1 hour later, they will receive a PET/CT scan. Additionally, they will be contacted the next day to inquire again about any side effects. If the participant's routine care involves repeat imaging of cancer, then the CFA PET/CT scan will be repeated at that time, which could be up to 365 days after the first CFA PET/CT scan.
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
- •Histologically or cytologically proven metastatic cancer (including carcinoma, adenocarcinoma, sarcoma, or neuroendocrine cancer).
- •Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest/abdomen/pelvis.
- •Subjects must have measurable disease per RECIST 1.1
- •Over 18 years of age
- •ECOG performance status 0-1
- •Adequate organ function as defined by the following criteria (labs may be no more than 4 weeks prior to the screening date):
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) <= 2.5 x laboratory upper limit of normal (ULN)
- •Total serum bilirubin <= 2.0 x ULN
- •Absolute neutrophil count (ANC) >= 1500/uL
- •Platelets >= 75,000/uL
- •Hemoglobin >= 8.0 g/dL
- •Serum calcium <= 12.0 mg/dL
- •Serum creatinine <= 2.9 mg/dL
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
- •Patient is able to remain still for the duration of the imaging procedure (up to one hour).
排除标准
- •Within 6 months prior to enrollment on this study: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.
- •Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects.
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
研究组 & 干预措施
18F-Clofarabine
18F-Clofarabine as PET imaging agent for measuring the activity of deoxycytidine kinase (DCK) in various normal and abnormal tissues in cancer participants before and after therapy
干预措施: 18F-Clofarabine (Drug)
结局指标
主要结局
Evaluate CFA as a PET imaging agent
时间窗: up to 60 minutes after CFA PET
Establish the image-based biodistribution of CFA, a new tracer for imaging DCK enzyme activity. DCK converts the inactive prodrug clofarabine into its active form. Thus, the degree of DCK expression in normal and abnormal tissues may predict drug effects and effectiveness. The uptake of the radiotracer (SUVs) will be measured quantitatively from PET images taken at 60 min post-injection of \[18F\]CFA.
次要结局
- Correlate CFA uptake with PFS(up to 12 months after CFA PET)
- Correlate CFA uptake with OS(up to 12 months after CFA PET)
- Correlate CFA uptake with conventional imaging(up to 3 months after CFA PET)
- Adverse Events(within 48 hrs of radiotracer administration)
研究者
Roberto Vargas
PI
Case Comprehensive Cancer Center