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临床试验/NCT03116945
NCT03116945Unknown2 期

68Gallium Citrate Imaging in Newly Diagnosed Hepatocellular Carcinoma

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
18
试验地点
1
主要终点
Uptake of positron emitting radiotracer, 68Gallium Citrate will be measured in the lesions of hepatocellular carcinoma.

研究概览

简要总结

The aim of the present study is to validate the uptake of novel, positron emitting radiotracer, 68Gallium Citrate in hepatocellular carcinoma(HCC). The investigators also aim to evaluate the sensitivity of 68Gallium (68Ga)-citrate positron emission tomography/computed tomography (PET/CT) for the identification of intrahepatic HCC lesions in comparison with existing modalities: computed tomography (CT) alone and magnetic resonance imaging (MRI). The investigators expect that 68Ga-citrate PET/CT will offer a sensitive functional imaging modality for identification of HCC lesions in the liver. The investigators intend to use the results of this preliminary study to fuel further studies in the utility of 68Ga-citrate PET/CT for HCC treatment monitoring.

详细描述

Hepatocellular carcinoma (HCC) is a malignancy of the liver with very high mortality. Management of HCC often involves interventional and surgical therapies that distort surrounding liver morphology. For this reason, current morphologic imaging techniques following these therapies often fail to distinguish between residual tumor and post-therapeutic morphologic changes. Therefore, there is the need for an effective imaging technique in therapy monitoring for HCC.

Functional imaging techniques are commonly used in other cancers for effective therapy monitoring. Functional imaging in HCC with single photon emitting gallium radioisotopes has been explored in the past but have not been used routinely due to poor resolution of images. 68Gallium-citrate PET/CT can generate high resolution images that specifically target HCC cells regardless of liver morphology. This makes 68Gallium-citrate PET/CT an ideal imaging modality for HCC following therapies that distort liver morphology.

Before determining its efficacy in therapy monitoring, The investigators aim to demonstrate the ability for 68Gallium-citrate PET/CT to localize known intrahepatic HCC lesions.

In this pilot study, 18 subjects with newly diagnosed HCC will be recruited. Each subject will undergo a 68Gallium-citrate PET/CT scan within 6 weeks of radiographic diagnosis. Foci of abnormal radiotracer uptake on these scans will be tabulated and compared to clinically-indicated morphologic imaging. The investigators expect that 68Gallium-citrate PET/CT will offer a sensitive functional imaging modality for identification of HCC lesions in the liver. The investigators intend to use the results of this preliminary study to form the basis for grant applications to extra-mural funding agencies. These subsequent grant applications will focus on further studies in the utility of 68Gallium-citrate PET/CT for HCC therapy monitoring and metastatic work-up.

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

入选标准

  • At least one biopsy-confirmed or Liver Imaging Reporting and Data System (LI-RADS)- 5 HCC lesion, diagnosed within the past 6 weeks.
  • Lesion size greater than or equal to 3cm
  • At least one triple-phase CT or MRI of the liver prior to medical or surgical therapy

排除标准

  • Pregnant or breast-feeding women.
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Inability to consent
  • Prior medical or surgical therapy for HCC, including chemoembolization, radiofrequency ablation, and lobectomy
  • Known or suspected hypersensitivity to metals or gallium

研究组 & 干预措施

Drug; 68Gallium Citrate

Experimental

Procedure: PET/CT Imaging

干预措施: 68Gallium Citrate (Drug)

结局指标

主要结局

Uptake of positron emitting radiotracer, 68Gallium Citrate will be measured in the lesions of hepatocellular carcinoma.

时间窗: One Year

For each subject, presence and location of abnormal radiotracer localization will be recorded. Tumor volume will be measured on CT, MRI, and PET/CT images using the MIM software. Region-of-interest (ROI) will be drawn around each area of morphologic abnormality on PET/CT images to calculate a mean standardized uptake value (SUV), a maximum SUV, and a target-to-background ratio.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nasrin Ghesani

Associate Professor

Rutgers, The State University of New Jersey

研究点 (1)

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