Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
研究概览
简要总结
This is a prospective study which aims to validate a new diagnostic approach in the tissue characterization of adrenal tumors indeterminate on conventional imaging. For this purpose, it is not necessary to have a control group since the diagnostic accuracy in a well defined subset of patients.
Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3 : 6 months post-PET. Visit 4 : 12 months post-PET.
详细描述
Primary objective The primary objective is to assess the diagnostic accuracy of FDG-PET, particularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Secondary objectives
- To assess the diagnostic accuracy of the tumor SUVmax, and SUVmax of the tumor/mean SUV of the liver.
- To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score.
- To evaluate the impact of the use of FDG-PET on the treatment options.
- To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
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
- 否
入选标准
- •Adult ≥ 18 yrs, male or female;
- •Indeterminate adrenal tumor (6.3.1.). The CT must include the calculation of SD and contrast washout and should have been performed within the 30 days before the inclusion visit (visit 0) ;
- •Patient insured with public health care system ;
- •Patient who accept to participate to the study and to sign the consent document form.
排除标准
- •Technical inability to perform FDG-PET.
- •Patient's death before final diagnosis.
结局指标
主要结局
diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
时间窗: 3 YEARS
次要结局
- assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.(3 YEARS)
- To evaluate the impact of the use of FDG-PET on the treatment options(3 years)
- To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score(3 years)
- To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).(3 years)