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临床试验/NCT03242811
NCT03242811已完成不适用

Swedish Age Assessment Study -SAAS Study to Deepen the Knowledge of Magnetic Camera Examinations as a Method for Medical Age Assessment

Berit Larsson3 个研究点 分布在 1 个国家目标入组 958 人开始时间: 2017年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Berit Larsson
入组人数
958
试验地点
3
主要终点
Number of participants with correctly classified age (below or above 18 years) when 5 different growth zones in the knee, ankle and wrist are examined by MRI and analysed individually and in combination to determine the maturity.

研究概览

简要总结

It is important that asylum seekers should have as accurate age assessment as possible and that children's fundamental rights are met by choosing methods based on best available knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for methods of medical age assessment of whether a person is over or under 18 years of age.

The primary issue is to investigate whether five selected growth zones in knee joint, ankle and wrist individually or in combination can better determine the 18-year limit compared with previous research.

详细描述

Swedish Age Assessment study is conducted with the aim of

  • Deepening the knowledge of age-assessment methodology with magnetic camera examinations among born and registered in Sweden aged 14.0 through 21.5 years
  • With a magnetic camera, investigate whether five selected growth zones in the knee joint and ankle joint (distal femur, proximal tibia, distal tibia and calcaneus) and distal radius (wrist) individually or in combination can better determine the 18-year limit compared with previous research
  • To investigate how gender and growing environment can affect the end of growth zones

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
14 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy children / young adults without prior illness (such as asthma, growth hormone treatment, prolonged peroral cortisone treatment, cancer treatment, diabetes, rheumatic disease) that may have affected growth can be included in the study.

排除标准

  • Children or adolescents with ongoing drug treatment for chronic disease.
  • Contraindication against MRI examination
  • Pregnancy

结局指标

主要结局

Number of participants with correctly classified age (below or above 18 years) when 5 different growth zones in the knee, ankle and wrist are examined by MRI and analysed individually and in combination to determine the maturity.

时间窗: 1 day

With 1.5 Tesla magnetic camera with dedicated cartilage sequence, selected growth zones will be investigated: knee joint, ankle joint including heel leg and wrist. The non-dominant body half will be investigated. In order to evaluate the growth zone with the highest precision, we have chosen T2-weighted gradient-recalled echo sequence, called mFFE / MERGE® / MEDIC® by various suppliers. The sequence is used in the clinical practice to assess various types of abnormalities in the cartilage. Two independent and blinded child radiologists shall examine MR images of 5 growth zones of each participant. All sections of each growth zone are to be examined and the cut is selected which shows the highest degree of closing / maturity for grading. Each growth zone will be examined and classified as being mature or non-mature.

次要结局

未报告次要终点

研究者

发起方
Berit Larsson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Berit Larsson

Unit Manager Karolinska Trial Alliance

Karolinska Institutet

研究点 (3)

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