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临床试验/NCT04154241
NCT04154241Unknown不适用

Developing a Method Using PET-MR to Improve Staging and Monitoring of Neuroendocrine Tumor

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 50 人开始时间: 2020年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
主要终点
Patients who preformed PET/MR.

研究概览

简要总结

euroendocrine tumors (NETs) are neoplasms that originate from diffuse neuroendocrine system which consist about 17 types of different neuroendocrine cells. These cells combine properties of nerve cells with properties of endocrine cells, that is they receive neuronal signal and produce hormones.The most common locations for NETs are the lungs and organs of the gastroenteropancreatic (GEP) system, however they can be found in any other organ in the body . Clinically, functional NET cells secrete hormones which cause symptoms such as diarrhea or flushing, however non-functional NET cells also exist posing a challenge in the identification and diagnosis of the disease . Besides surgery to remove the tumor, there are numerous of treatment options for systemic handling of the NETs. These treatments include: somatostatin analogues, interferon, chemotherapy, transarterial (chemo) embolisation, radiofrequency ablation, sunitinib, everolimus and radionuclide targeted therapy. The choice of treatment depends on the correct characterization of the NET, primary tumor location, tumor subtype, grade and stage of the disease . Biomarkers for NETs serve a critical role in the diagnosis stage, where it is highly important to identify the NET type and precise location. Furthermore, selecting the correct biomarkers for monitoring the disease is important to predict response for treatment and allow the choice of the right treatment from the large variety of treatment options. NET biomarkers include circulating biomarkers such as Chromogranin A, Ki67, Neuron Specific Enolase (NSE), 5 hydroxyindoleacetic acid (5HIAA) and many others found in blood samples, or in the tumor tissue . Beside the circulating biomarkers, imaging biomarkers plays a central role in diagnosis, staging, treatment selection and follow-up of NETs . Current imaging tools are morphological modalities such as CT, MRI and Ultrasound and molecular imaging. Several types of molecular imaging techniques are performed to characterize NETs: single photon emission computed tomography (SPECT) with 111In-pentetreotide, largely superseded now by positron emission tomography (PET) with 68Ga-labeled somatostatin analogs, is used to identify the somatostatin receptor status.

详细描述

18F-DOPA and 11C-5-HTP are used to evaluate neuroendocrine metabolism . 18-fluoro-deoxy-glucose (FDG) PET is usually a poor indication for NETs since these neoplasms tend to be metabolic inactive, and thus FDG-PET is only used for high grade more aggressive NETs . Only a combination of several biomarkers together can lead to NET description that allows treatment selection and to some extent prediction of treatment success.

In this study the investigators wish to take advantage of the new hybrid PET-MR and use it to find new methods to characterize NETs. Only very few PET-MR studies have been performed with correlation to NETs and they showed the potential of this tool for tumor characterization .

The investigators plan to integrate PET-MR with big data analysis methods to obtain an improved tool for staging, characterization and monitoring NETs.

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

入选标准

  • •A cohort of patients that were diagnosed with NET using biopsy.

排除标准

  • •Pregnant or breast feeding patients.

研究组 & 干预措施

neuroendocrine tumor Patients

Experimental

A cohort of patients that were diagnosed with NET using biopsy.

干预措施: PET/MR scan (Diagnostic Test)

结局指标

主要结局

Patients who preformed PET/MR.

时间窗: 1 year

The investigators develop new methods for the characterization and monitoring of NETs using the latest state of the art PET-MR technology combined with big data analysis methods in order to obtain a more accurate, specific and sensitive biomarker.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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