Swedish Age Assessment Study (SAAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Age Determination by Skeleton
• Intervention / Treatment: Diagnostic test: MRI scan of knee, ankle and wrist

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 958
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Karlskrona, Sweden, 37179
    • Blekinge Institute of Technology
  • Stockholm, Sweden
    • Karolinska Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Examination by MRI; MRI scan of knee, ankle and wrist

Diagnostic test: MRI scan of knee, ankle and wrist; 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.; Other Names: Self assessment of puberty by Tanner scale; Questionnaire on socioeconomics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Berit Larsson
• Collaborators: Karolinska Institutet; Ministry of Health and Social Affairs, Sweden; Blekinge Institute of Technology
• Investigators: Principal Investigator: Sandra Diaz, MD, PhD, Karolinska Institutet; Principal Investigator: Johan Sanmartin Berglund, MD, PhD, Blekinge Institute of Technology; Study Director: Carl-Erik Flodmark, MD, PhD, Ministry of Health and Social Affairs, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Medical age assessment
• Other Study ID Numbers: SAAS 20170506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No