NCT05816005招募中不适用
Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2021年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Evaluation of diagnostic accuracy for extrapelvic disease detection using whole-body MRI
研究概览
简要总结
The aim of this prospective observational diagnostic study is to investigate the diagnostic accuracy od extrapelvic disease detection using Whole-body-MRI (WB-MRI) in patients with gynecologic cancer candidate to the pelvic exenteration.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Written Informed Consent
- •All patients with recurrent gynecological cancer that are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and palliative intent
- •Patients considered fit for srugery
排除标准
- •Controindication to MRI (Claustrophobia, implanted ferromagnetic materials or foreign objects, Known intolerance or controindication to the MRI contrast agent, cardiac pacemaker)
- •Individuals who are not able or willing to tolerate the required prologed stationary supine position during examination (approximately 40-60 minutes)
- •Patient unable to give informed consent
结局指标
主要结局
Evaluation of diagnostic accuracy for extrapelvic disease detection using whole-body MRI
时间窗: Through study completion, an average of 2 yearS
次要结局
- Agreement between WB-MRI and PET-CT in detecting extrapelvic involvement(Through study completion, an average of 2 yearS)
研究者
研究点 (1)
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