SAAS: Swedish Age Assessment Study

• Sponsor: Berit Larsson (Other)
• Overall Status: Completed
• CT.gov ID: NCT03242811
• Collaborator: Blekinge Institute of Technology (Other), Ministry of Health and Social Affairs, Sweden (Other), Karolinska Institutet (Other)
• Enrollment: 958
• Locations: 2
• Arm: 1
• Actual Duration (Months): 10.4
• Patients Per Site: 479
• Patients Per Site Per Month: 45.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Determination by Skeleton	Diagnostic Test: MRI scan of knee, ankle and wrist	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 958 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Swedish Age Assessment Study -SAAS Study to Deepen the Knowledge of Magnetic Camera Examinations as a Method for Medical Age Assessment
• Actual Study Start Date: Jun 16, 2017
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blekinge Institute of Technology	Karlskrona		Sweden	37179
2	Karolinska Institute	Stockholm		Sweden

Sponsors and Collaborators

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

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Berit Larsson, Unit Manager Karolinska Trial Alliance, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03242811
• Other Study ID Numbers: SAAS 20170506
• First Posted: Aug 8, 2017
• Last Update Posted: Jun 6, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Berit Larsson, Unit Manager Karolinska Trial Alliance, Karolinska Institutet: Medical age assessment

Study Results

No Results Posted as of Jun 6, 2018