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临床试验/NCT04469244
NCT04469244已完成不适用

Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
2
主要终点
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.

研究概览

简要总结

The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient having performed a PET/CT examination at 18F-FDOPA for his glioma in the nuclear medicine department of the CHRU de Brabois for which the raw data are available;
  • Person who received full information on the organization of the research and did not object to the use of these data;
  • Patients affiliated to a social security scheme

排除标准

  • - Person who received full information on the organization of the research and who objected to the use of the data
  • Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
  • A person of full age who is unable to give consent and who is not subject to a legal protection measure.

结局指标

主要结局

Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.

时间窗: 1 year

Evaluating the performance of radiomics use in gliomas at initial diagnosis

次要结局

  • Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence(1 year)
  • Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.(1 year)
  • Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data(1 years)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antoine VERGER

MD, PhD

Central Hospital, Nancy, France

研究点 (2)

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Evaluation of the Use of Radiomics in 18F-FDOPA PET... | 临床试验