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临床试验/NCT02940041
NCT02940041终止不适用

Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchymal Malignant Tumors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau0 个研究点目标入组 15 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
15
主要终点
Concordance Between Gynaecologic Sonography Amd Pelvic MRI

研究概览

简要总结

Determine the concordance between gynaecological sonography and pelvic MRI for the pre-surgical diagnosis of uterine malignant tumors.

详细描述

The hypothesis that will be evaluated with this study is the concordance between the sonographic assessment following the terms and definitions to describe uterine pathology proposed by Morphological Uterus Sonographic Assessment (MUSA) and the pelvic MRI for the pre-surgical diagnosis of malignant mesenchymal uterine tumors in patients affected of symptomatic leiomyomas with clinical or sonographic risk factors for atypical fibroids.

If both explorations have the same efficiency for the diagnosis, one of those should be avoided, diminishing the costs and surgery delay for these patients.

Those women with uterine leiomyoma who present >2 risk factors for uterine malignant mesenchymal tumors OR with sonographic criteria for atypical leiomyoma will be invited to participate in the study and will sign the informed consent.

After this first visit, the patient will undergo a gynecological sonography, serum lactate dehydrogenase (LDH) determination and a pelvic MRI, as it is done in our regular clinical practice.

All explorations will be performed in the same study center and will be done by independent physicians.

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

  • >18 years old
  • Accept to participate in the study
  • uterine leiomyomas who have >2 risk factors for mesenchymal uterine malignant tumor OR sonographic suspicion of atypical leiomyoma.

排除标准

  • < 18 years
  • Not being capable of understanding the study design

结局指标

主要结局

Concordance Between Gynaecologic Sonography Amd Pelvic MRI

时间窗: We expect to recruit 50 patients in 1 year period

次要结局

  • Determine sensibility for sonographic and MRI specific parameters on diagnosis uterine malignant tumors(We expect to recruit 50 patients in 1 year period)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

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