An Exploratory Study of Hypoxia Imaging Using 18F-FAZA-PET in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine + TH-302/Placebo (MAESTRO: EMR200592-001)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%.
研究概览
简要总结
Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.
This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment.
The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.
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
- •Have consented to participating on the first-line Gemcitabine + TH-302/placebo (study number EMR200592-001) study
- •Age 18 years or older
- •Cytologic/histologic diagnosis of pancreatic adenocarcinoma
- •Advanced stage pancreatic cancer: locally advanced or metastatic.
- •No prior chemotherapy for advanced/metastatic disease. Adjuvant chemotherapy allowed if completed > 6mths from study entry. Prior radio-sensitizing doses of 5-FU or gemcitabine also allowed.
- •ECOG performance status 1 or less
- •Adequate end organ and marrow function
- •Measureable or non-measureable disease by RECIST 1.1
- •Female patients of child-bearing potential must have a negative serum pregnancy test (BhCG) and must agree to abstinence or use adequate contraception for the duration of the study
- •Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) breast disease).
- •Ability to provide written informed consent
- •Must be able to lie flat comfortably for 30 to 60 min to complete imaging study
排除标准
- •Inability to lie supine for 30 to 60 minutes
- •Concurrent second primary
- •Life expectancy of less than 12 weeks
- •On treatment with disulfiram (antabuse) due to [18F]FAZA injection containing up to 10% (v/v) ethanol in PBS (phosphate-buffered saline)
研究组 & 干预措施
FAZA PET-CT scan
FAZA PET-CT imaging within 14 days of treatment from the EMR200592-001 study.
FAZA PET-CT imaging about 5 weeks after start of treatment from the EMR200592-001 study.
干预措施: 18F-Fluoroazomycin arabinoside (Drug)
结局指标
主要结局
Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%.
时间窗: 2 years
Number of enrolled patients that complete all required scans compared to total number of patients enrolled in the study is at least 70%.
时间窗: 2 years
Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment.
时间窗: 2 years
次要结局
- Compare the changes in tumor hypoxia with response to chemotherapy treatments.(2 years)
- Evaluate how FAZA is taken in by different tumor types within individual patients.(2 years)
- Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.(2 years)