跳至主要内容
临床试验/NCT05816005
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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