Evaluation of the Fractional Uptake Rate (FUR) in 18F-FDG PET/CT to Assess Tumour Metabolic Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Superiority of the FUR compared to the SUV
研究概览
简要总结
The goal of this study is to evaluate the use of new method to quantify the amount of sugar a tumor consumes using PET/CT. The main questions it aims to answer are:
- Is the new quantification method superior with respect to the method currently used in the clinic?
- Does the new quantification method provide accurate assessment of the sugar consumption of tumours?
Participants who will undergo a standard care FDG PET/CT scan will in additional receive a dynamic PET/CT scan prior to the standard care scan. In addition blood samples will be drawn at three time points during the examination.
详细描述
As most tumours have a high glucose consumption, important information on tumour metabolism can be obtained from PET imaging using 18F-FDG as a radioactive glucose analogue. From literature it is known that quantitative analysis improves the clinical value of 18F-FDG PET. However, instead of measuring the true tumour glucose consumption Km, in current clinical practice the 18F-FDG uptake is measured at a certain time after administration as a surrogate for Km, the so-called standardized uptake value (SUV). As the SUV suffers from a number of important shortcomings, discrepancies between Km and the SUV have been reported which may lead to erroneous conclusions regarding disease progression based on the SUV.
Alternatively, pharmacokinetic modelling approaches facilitate accurate Km assessment. Unfortunately, these approaches typically require complex mathematical modelling, lengthy dynamic PET imaging and/or invasive arterial blood sampling and are therefore not compatible to current clinical oncologic 18F-FDG PET scanning. However, from these models it can be derived that at late time points after administration Km can be approximated using a simplified approach known as the fractional uptake rate (FUR). Our hypothesis is that the correlation between the FUR and Km is superior compared to the correlation between the SUV and Km. Therefore we expect that quantification of 18F-FDG PET images based on the FUR is superior to SUV quantifications.
The results of this study may therefore lead to a new and improved method to quantify oncologic PET images which may enhance the diagnostic value of PET. In particular, this method may lead to a more accurate assessment of tumour response to therapy and may therefore prevent continuation of unsuccessful therapy or termination of a successful therapy.
Primary objective:
To investigate whether the correlation between the FUR and Km is superior compared to the correlation between the SUV and Km.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 who receive an 18F FDG PET/CT scan as part of standard care
- •Be competent and be 18 years of age or older
排除标准
- •Diabetes (fasted blood glucose > 7 mmol/L)
- •Not fasted > 4 hours
- •Physical exercise within 24 hours
- •Earlier treatment for carcinoma with radio/chemo-therapy
- •Active inflammation (fever > 38 degrees, CRP > 5)
- •Any condition or medical indication (such as claustrophobia) that indicates that the patient will not be able to lie still for the duration of the dynamic PET/CT examination
- •Pregnant or breast feeding
结局指标
主要结局
Superiority of the FUR compared to the SUV
时间窗: Time of PET examination
The correlation between the fractional uptake rate (FUR) and the metabolic glucose consumption (Km) will be compared to the correlation between the standardized uptake value (SUV) and Km
次要结局
- FUR validation to quantify tumour metabolic activity(Time of PET examination)
- Impact of patient-specific input function(Time of PET examination)
研究者
Roel Wierts
Medical physicist
Academisch Ziekenhuis Maastricht