Swedish Age Assessment Study

NCT03242811 | Completed

• 1 other identifier: SAAS 20170506
• Study Type: interventional
• Target: 958
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Age Determination by Skeleton

Keywords

Medical age assessment

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 day

Study Arms (1)

Examination by MRI

EXPERIMENTAL

MRI scan of knee, ankle and wrist

Diagnostic Test: MRI scan of knee, ankle and wrist

Interventions

MRI scan of knee, ankle and wrist DIAGNOSTIC_TEST

At the day of the intervention, the subject is informed about the study by a nurse and provides written informed consent. Girls must leave urine tests to rule out pregnancy. The questionnaire for the study is answered by the subject and weight and length are measured. The subject is asked to self-assess his/her puberty. After detailed information on how a magnetic camera examination is carried out, an examination of five selected growth zones (knee joint, ankle joint including heel leg and wrist) is performed using 1.5 Tesla magnetic camera with dedicated cartilage sequence.

Also known as: Self assessment of puberty by Tanner scale, Questionnaire on socioeconomics

Examination by MRI

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Berit Larsson: lead
• Blekinge Institute of Technology: collaborator
• Ministry of Health and Social Affairs, Sweden: collaborator
• Karolinska Institutet: collaborator

Study Sites (2)

Blekinge Institute of Technology

Karlskrona, 37179, Sweden

Location

Karolinska Institute

Stockholm, Sweden

Location

Study Officials

• Sandra Diaz, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Johan Sanmartin Berglund, MD, PhD

  Blekinge Institute of Technology

  PRINCIPAL INVESTIGATOR

• Carl-Erik Flodmark, MD, PhD

  Ministry of Health and Social Affairs, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Unit Manager Karolinska Trial Alliance

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: August 8, 2017
• Study Start: June 16, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)