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临床试验/NCT03414021
NCT03414021招募中不适用

Quantification in Nuclear Medicine: Interest of the in SPECT-CT Scan SUVspect in Thea New Generation of Gamma-cameras With Semiconductor. Data Collection for the Constitution of an Observatory of Scintigraphies

Lille Catholic University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
2
主要终点
SUVspect

研究概览

简要总结

Since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in 2016), offer a technological breakthrough by providing an additional information. They allow "to quantify" for the 1st time in clinical routine conditions, the quantity of radioactivity, by means of a "SUVspect", in a volume of interest, while respecting the recommendations of best practice of the learned societies of French nuclear medicine (SFMN), European (EANM) and American (SNM), without injection of tracer nor acquisition or additional irradiation. The SUVspect is therefore an indicator of the quantity of tracer in a given volume of acquisition.

Until now, the interpretation criteria of scintigraphies are based on the homogeneity of distribution of a tracer in the explored organ (for single organs such as the heart or the thyroid, for example) or in the asymmetry of distribution of the tracer (for the double organs, such as the kidney or the joints).

This new gamma-camera allows to study the distribution of the radio-tracers in "list" mode, allowing to retrospectively reconstruct the images in various ways (for example, by modifying the size of the matrix of acquisition, the energy windows, the time of acquisition). Therefore, we can simulate and propose modifications in current procedures.

Every patient referred to our department of nuclear medicine to undergo a scintigraphy with a tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an examination by this gamma-camera, to be the object of this study, and to profit from this additional information.

So, without changing the diagnosis or the usual care, we wish to take advantage of this additional information to improve the criteria of interpretation of our examinations.

This possibility being new, there is no available bibliography (our department is the 5th department of nuclear medicine in Europe to equip itself with this large field-of-view gamma-camera CZT, the DNM 670, made by General Electric), while 2961 articles speak about the SUVmax (in PET) in Pubmed.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • informed adult patients referred to our department of nuclear medicine for a nuclear medicine exploration

排除标准

  • Refusal to participate
  • Patient under guardianship

结局指标

主要结局

SUVspect

时间窗: 5 years

Pathological threshold (SUVspect) for every type of scintigraphy

次要结局

  • duration of image acquisition(5 years)
  • Matrix size(5 years)

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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