18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tumor drug uptake within PDAC tumors prior at pre-treatment baseline
研究概览
简要总结
The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.
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
- •Patients with histologically-confirmed (confirmed at MSKCC) PDAC
- •Patients must be ≥ 18 years old
- •Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- •Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.
- •Karnofsky Performance Status ≥70%.
- •Life expectancy ≥3 months.
- •A negative serum pregnancy test, within 1 week of the procedure, if the patient is female of reproductive potential.
排除标准
- •Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- •Women who are pregnant or breast-feeding.
研究组 & 干预措施
Participants with pancreatic ductal adenocarcinoma (PDAC)
Participants will have histologically-confirmed pancreatic ductal adenocarcinoma (PDAC). The experimental design of this study is to perform a single [18F]-FAC PET scan prior to the administration of chemotherapy with an optional second [18F]-FAC PET scan procedure during SOC treatment to observe changes in tumor uptake and biodistribution. Patients will be offered a second [18F]-FAC PET scan procedure during their SOC treatment. This second scan will be optional.
干预措施: PET Scan (Diagnostic Test)
结局指标
主要结局
Tumor drug uptake within PDAC tumors prior at pre-treatment baseline
时间窗: Baseline
The primary objective of this study is to obtain preliminary data of tumor drug uptake profile, concentration and distribution within PDAC tumors prior at pre-treatment baseline
次要结局
- changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy.(2 years)