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临床试验/NCT05871892
NCT05871892招募中不适用

Clinical Impact of 18F-FDGal PET/CT and PET/MRI in Patients Suspected of or Diagnosed With Hepatocellular Carcinoma

University of Aarhus2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2023年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
2
主要终点
Sensitivity and specificity of the PET tracer 18F-FDGal

研究概览

简要总结

Hepatocellular carcinoma (HCC) is the most common primary liver tumor and the fourth leading cause of cancer-related death worldwide. In Denmark, the incidence of HCC is 5.2 per 100.000 population per year with a dismal prognosis as the median survival time is just 7.7 months.

Extrahepatic spread of HCC is common at advanced stages with haematogenous spread to lungs, bones and adrenal glands or lymphatic spread to regional lymph nodes.

The majority of patients who develop HCC have cirrhosis of the liver and in these patients, diagnosis can be made non-invasively with characteristic contrast-enhancement pattern on computed tomography (CT) and/or magnetic resonance imaging (MRI). Although contrast-enhanced CT and MRI are considered equal in current guidelines, MRI may have a better sensitivity especially for small lesions.

Positron emission tomography (PET) is a molecular imaging technique based on the injection of a very small dose of a tracer substance labelled with a positron emitting radioisotope. PET with the glucose tracer 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) is an important tool in the staging of many cancer forms, but it is not included in the international guidelines for management of HCC because of suboptimal sensitivity of only up to 50-60 % for HCC situated in the liver.

In Aarhus, the liver specific tracer 18F-FDGal has been developed. It is a fluorine-18 labelled galactose analogue which in the human body is trapped in hepatocytes by phosphorylation by galactokinase. The first study of the diagnostic use of 18F-FDGal PET/CT in patients suspected of having HCC was published in 2011. The study showed good clinical potential for 18F-FDGal as a tracer for detection of intra- as well as extrahepatic HCC.

The aim of the present project is to establish the clinical impact and utilization of 18F-FDGal PET/CT and PET/MRI in patients suspected of having HCC or diagnosed with HCC, for staging and evaluation of treatment response including effect of treatment on liver function.

Hypotheses:

I. Adding 18F-FDGal PET/CT or PET/MRI to diagnostic work-up of patients suspected of or diagnosed with HCC will add to the establishment of a definitive diagnosis and improve staging and thus choice of treatment.

II. The uptake pattern of 18F-FDGal in HCC provides prognostic information and can be used to evaluate regional metabolic liver function before and after loco-regional treatment.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly-referred patients suspected of or diagnosed with HCC
  • Age above 18 years

排除标准

  • The patient does not want to take part in the study
  • The responsible investigator determines that the patient is not qualified for a PET scan.
  • Patients who are offered systemic chemotherapy or best supportive care will be excluded.
  • Renal insufficiency (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area).
  • Pregnant or nursing patients.

结局指标

主要结局

Sensitivity and specificity of the PET tracer 18F-FDGal

时间窗: Five years

The ability of the scan 18F-FDGal PET/CT or PET/MRI to correctly identify lesions representing intrahepatic and/or extrahepatic hepatocellular carcinoma.

Metabolic function of the liver evaluated by the PET tracer 18F-FDGal

时间窗: Five years

The ability of the scan 18F-FDGal PET/CT or PET/MRI to determine the loco-regional treatment effects on metabolic liver function in other regions of the liver.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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