跳至主要内容
临床试验/NCT06117410
NCT06117410招募中不适用

Assessing Ultrasonographic Severity of Adenomyosis - a Feasibility and Interobserver Study

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Quantifiable offline severity method

研究概览

简要总结

The aim of this pilot study is to develop a feasible and quantifiable ultrasonographic method to grade the severity of adenomyosis and to determine the interobserver variation.

详细描述

The investigators will conduct a prospective observational study in premenopausal women visiting the gynaecological outpatient clinic for an ultrasonographic exam. Patients are recruited when the diagnosis adenomyosis was made with transvaginal ultrasound (TVUS). Diagnosis adenomyosis requires at least one direct US feature of adenomyosis (subendometrial lines or buds, hyperechogenic islands or myometrial cysts). The sonographers obtain two-dimensional (2D) images, a grey-scale video-clip, elastography and power-doppler and micro-vascularity flow clips and images, and a three-dimensional (3D) uterine volume. The investigators will evaluate the collected images, clips and 3D-volumes with different methods to assess severity and test the feasibility and inter-observer agreement of these methods.

At the outpatient clinic, all real-time TVUS are assessed in a systematically manner by the sonographers and the presence of MUSA (Morphological Uterus Sonographic Assessment) features (subendometrial lines or buds, hyperechogenic islands or myometrial cysts, asymmetrical myometrium, globular uterus, translesional vascularity, fan-shaped shadowing, interrupted/irregular junctional zone) and an estimation of the affected myometrium, graded in mild (<25% affected myometrium), moderate (25%-50% affected myometrium) or severe (>50% affected myometrium) are reported. Clinical data, medical history, reason for visit, pain score in numeric rating scale (NRS), pictorial blood assessment chart (PBAC) score, etc. is collected.

Based on previous research and experience, four experts in gynaecological sonography select multiple offline methods using 5D Viewer software, for the evaluation and quantification of the severity of adenomyosis.

All the ultrasounds will be coded, so the assessors are blinded for patients demographics, medical history, symptomatology and the assessment by the sonographers.

Two experienced gynaecologist and one resident in gynaecology will test these methods for feasibility. Feasibility will be scored regarding technique, time and interpretation of MUSA features. The selected feasible methods will be tested for inter-observer variation. Finally a comparison of the severity evaluation by the assessors done with the new methods and the results of the severity estimation at the outpatient clinic will be made.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • at least one direct MUSA feature (lines and buds, hyperechogenic islands, cysts)
  • premenopausal, older than18 years

排除标准

  • hormonal medication
  • other reason for gynaecological symptoms, more evident than adenomyosis, e.g. deep infiltrating endometriosis, dominant uterine fibroids (>5cm, >5 myoma, intracavitary myoma), cervical or endometrial cancer.

结局指标

主要结局

Quantifiable offline severity method

时间窗: Baseline

Method using 5D viewer to assess severity of adenomyosis offline

次要结局

  • Amount of menstrual blood loss(Baseline)
  • Numbers of MUSA features(Baseline)
  • Dysmenorrhea(Baseline)
  • Real-time severity estimation(Baseline)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

J.A.F. Huirne

Prof. Dr.

Amsterdam UMC, location VUmc

研究点 (1)

Loading locations...

相似试验