Source and Prevention of Urinary Contamination of Vaginal Tampons During 18F-2-fluoro-2-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Examinations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of FDG Positive Tampoons
研究概览
简要总结
The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and can potentially impair image interpretation.
The aim of this study is to determine the etiology of this artefact and identify potential means how to prevent it.
详细描述
In this prospective, Institutional Review board approved study we included 44 women referred to FDG PET/CT for staging or follow-up in an oncology setting. All women were provided a normal commercial or modified vaginal tampon with a silicon coated base to be used during examination. Images were analyzed to determine the localization and the FDG uptake in the tampons. Between the uptake phase and imaging, all patients were asked to void. After image acquisition, tampons were individually analyzed for creatinine concentration, blood traces, position relative to the pubococcygeal line, and FDG activity. Statistical significance was determined by means of the Mann-Whitney U test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
randomly assigned to either modified or unmodified tampons
入排标准
- 年龄范围
- 20 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Modified vaginal tampons
Patients using modified vaginal tampons during FDG PET/CT
干预措施: modified vaginal tampon (Device)
Unmodified vaginal tampons
Patients using unmodified vaginal tampons during FDG PET/CT
干预措施: modified vaginal tampon (Device)
结局指标
主要结局
Number of FDG Positive Tampoons
时间窗: 1 month
Number of FDG positive Tampoons with an SUV \> 3
次要结局
- Tampon Position Relative to the Pubococcygeal Line(1 month)
研究者
Irene Burger
Attending physician
University of Zurich